Summary of Safety and Clinical Performance

Duo-Flow® Side x Side Catheter

SSCP Document Number: SSCP-029
Revision Number: 3
Revision Date: 16-Sep-24

Important Information

This Summary of Safety and Clinical Performance (SSCP) is intended to provide public access to an updated summary of the main aspects of the safety and clinical performance of the device. The information presented below is intended for patients or lay persons. A more extensive summary of safety and clinical performance prepared for healthcare professionals is found in the first part of this document.

The SSCP is not intended to give general advice on the treatment of a medical condition. Please contact your healthcare professional in case you have questions about your medical condition or about the use of the device in your situation. This SSCP is not intended to replace an Implant Card or the Instructions for Use to provide information on the safe use of the device.

1. Device Identification and General Information

Device Trade Name(s): Duo-Flow® Side x Side Catheter

Manufacturer Name and Address: Medical Components, Inc. 1499 Delp Drive Harleysville, PA 19438 USA

Basic UDI-DI: 00884908303MW

Date First CE Certificate Was Issued for This Device: Nov-97

Device Grouping and Variants

This document talks about hemodialysis tube [catheter] sets. These tubes are used for a short time and come in different sets. These devices are distributed as procedure trays. Procedure trays come in different configurations.

Variant Devices:

Variant Description Part Number(s)
11F x 12cm Curved Extensions Duo-Flow Side x Side 1176
11F x 12cm Straight Duo-Flow Side x Side 1084
11F x 13.5cm Curved Extensions Duo-Flow Side x Side 10540
11F x 15cm Curved Extensions Duo-Flow Side x Side 1174
11F x 15cm Straight Duo-Flow Side x Side 1085
11F x 20cm Curved Extensions Duo-Flow Side x Side 1175
11F x 20cm Straight Duo-Flow Side x Side 1086
11F x 24cm Straight Duo-Flow Side x Side 1246
12F x 13.5cm Curved Extensions Duo-Flow Side x Side 10011-8135-105C
12F x 13cm Curved Extensions Duo-Flow Side x Side 10011-813-100C
12F x 13cm Straight Duo-Flow Side x Side 10011-813-100
12F x 15cm Curved Extensions Duo-Flow Side x Side 10011-815-100C
12F x 15cm Straight Duo-Flow Side x Side 10011-815-100
12F x 20cm Curved Extensions Duo-Flow Side x Side 10011-820-100C
12F x 20cm Straight Duo-Flow Side x Side 10011-820-100
12F x 24cm Curved Extensions Duo-Flow Side x Side 10011-824-100C
12F x 24cm Straight Duo-Flow Side x Side 10011-824-100
14F x 13cm Curved Extensions Duo-Flow Side x Side 10067-813-100C
14F x 13cm Straight Duo-Flow Side x Side 10067-813-100
14F x 15cm Curved Extensions Duo-Flow Side x Side 10067-815-100C
14F x 15cm Straight Duo-Flow Side x Side 10067-815-100
14F x 20cm Curved Extensions Duo-Flow Side x Side 10067-820-100C
14F x 20cm Straight Duo-Flow Side x Side 10067-820-100
14F x 24cm Curved Extensions Duo-Flow Side x Side 10067-824-100C
14F x 24cm Straight Duo-Flow Side x Side 10067-824-100
9F x 12cm Curved Extensions Duo-Flow Side x Side 1177
9F x 12cm Straight Duo-Flow Side x Side 1124
9F x 15cm Curved Extensions Duo-Flow Side x Side 1178
9F x 15cm Straight Duo-Flow Side x Side 1125
9F x 20cm Straight Duo-Flow Side x Side 1126
Variant Description Part Number(s)

Procedure Trays:

Configurations of Procedure Trays:
Catalog Code Part Number Description
ARD1213C 10011-813-105C 12F X 13Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1213S 10011-813-105 12F X 13Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
ARD1215C 10011-815-105C 12F X 15Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1215S 10011-815-105 12F X 15Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
ARD1220C 10011-820-105C 12F X 20Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1220S 10011-820-105 12F X 20Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
ARD1224C 10011-824-105C 12F X 24Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1224S 10011-824-105 12F X 24Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
ARD1235C 10011-8135-105C 12Fx13.5Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1413C 10067-813-105C 14F X 13Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1413S 10067-813-105 14F X 13Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
ARD1415C 10067-815-105C 14F X 15Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1415S 10067-815-105 14F X 15Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
ARD1420C 10067-820-105C 14F X 20Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1420S 10067-820-105 14F X 20Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
ARD1424C 10067-824-105C 14F X 24Cm Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
ARD1424S 10067-824-105 14F X 24Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
ARD912S 1124 9F X 12Cm Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
DL 11/15 1085 11F X 15Cm Nikkiso Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
DL 11/20 1086 11F X 20Cm Nikkiso Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
DL 9/15 1125 9F X 15Cm Nikkiso Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
NDDLPC15 10011-815-112C 12F X 15Cm Nipro Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
NDDLPC20 10011-820-112C 12F X 20Cm Nipro Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
NDDLS20 10011-820-112 12F X 20Cm Nipro Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
NIDLC15K 10011-815-112C 12F X 15Cm Nipro Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
NIDLC20K 10011-820-112C 12F X 20Cm Nipro Jet Cath® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
NIDLS15K 10011-815-112 12F X 15Cm Nipro Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
NIDLS20K 10011-820-112 12F X 20Cm Nipro Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
NIDLS24K 10011-824-112 12F X 24Cm Nipro Jet Cath® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP114IJS= 1176 11F X 12Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP114MT= 1084 11F X 12Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP115IJS= 10540 11F X 13.5Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP116IJS= 1174 11F X 15Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP116MT= 1085 11F X 15Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP118IJS= 1175 11F X 20Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP118MT= 1086 11F X 20Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP119MT= 1246 11F X 24Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP125IJSA 10011-813-100C 12F X 13Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP125MTA 10011-813-100 12F X 13Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP126IJSA 10011-815-100C 12F X 15Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP126MTA 10011-815-100 12F X 15Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP128IJSA 10011-820-100C 12F X 20Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP128MTA 10011-820-100 12F X 20Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP129IJSA 10011-824-100C 12F X 24Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP129MTA 10011-824-100 12F X 24Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP145IJSA 10067-813-100C 14F X 13Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP145MTA 10067-813-100 14F X 13Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP146IJSA 10067-815-100C 14F X 15Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP146MTA 10067-815-100 14F X 15Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP148IJSA 10067-820-100C 14F X 20Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP148MTA 10067-820-100 14F X 20Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP149IJSA 10067-824-100C 14F X 24Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP149MTA 10067-824-100 14F X 24Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP94IJS= 1177 9F X 12Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
XTP94MT= 1124 9F X 12Cm Duo-Flow® Side X Side Double Lumen Hemodialysis Catheter Basic Set
XTP96IJS= 1178 9F X 15Cm Duo-Flow® Side X Side Double Lumen Curved Extension Hemodialysis Catheter Basic Set
Configurations of Procedure Trays:
Catalog Code Part Number Description

Configurations of Procedure Trays:

Configuration Type
Basic Set:

2. Intended Use of the Device

Intended Purpose: The Duo-Flow® Side x Side Catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom immediate central venous vascular access for short-term hemodialysis is deemed necessary based on the direction of a qualified, licensed physician. The catheter is intended to be used under the regular review and assessment of qualified health professionals. This catheter is for Single Use Only.

Indication(s): The Duo-Flow® Side x Side Catheter is indicated for short-term use where vascular access is required for less than 14 days for the purpose of hemodialysis.

Intended Patient Group(s): Duo-Flow® Side x Side catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom immediate central venous vascular access for short-term hemodialysis is deemed necessary based on the direction of a qualified, licensed physician. The catheter is not intended for use in pediatric patients.

Contraindications and/or Limitations:

  • Known or suspected allergies to any of the components of the catheter or the kit.
  • This device is contraindicated for patients exhibiting severe, uncontrolled coagulopathy or thrombocytopenia.

3. Device Description

Device Image

Device Name: Duo-Flow® Side x Side Catheter

Description of Device: The Duo-Flow® Side x Side Catheter has two separate paths to move blood in and out of the body. Each path has a different colored tube. The tubes connect to a part that is shaped like a hub. Both paths have small holes to help the blood flow. The device contains a substance called Barium Sulphate to make it easier to see with X-rays. It comes in various sizes and shapes to fit the needs of the patient as determined by the doctor. The curved extensions devices are not suitable for femoral insertion.

Device Image

Device Name: Duo-Jet® Side x Side Catheter

Description of Device: The Duo-Jet® Side x Side Catheter has two separate paths to move blood in and out of the body. Each path has a different colored tube. The tubes connect to a part that is shaped like a hub. Both paths have small holes to help the blood flow. The device contains a substance called Barium Sulphate to make it easier to see with X-rays. It comes in various sizes and shapes to fit the needs of the patient as determined by the doctor. The curved extensions devices are not suitable for femoral insertion. Nipro Duo-Flow® Side x Side Catheter The Nipro Duo-Flow® Side x Side Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color-coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The curved extensions devices are not suitable for femoral insertion. Nikkiso Duo-Flow® Side x Side Catheter The Nikkiso Duo-Flow® Side x Side Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color-coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter is available in a variety of French sizes and lengths to accommodate physician preference and clinical needs.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weights of the 9F x 12cm straight catheter (7.87g) and the 14F x 24cm catheter with curved extensions (11.61g).

Material % Weight (w/w)
Polyurethane 37.37 - 48.13
Acetal co-polymer 20.64 - 24.95
Polyvinyl chloride 16.80 - 24.83
Acrylonitrile Butadiene Styrene 6.33 - 9.34
Vythene 0 - 5.76
Barium sulfate 1.16 - 5.23

Material % Weight (w/w)

Information on Medicinal Substances in the Device:

How the Device Achieves its Intended Mode of Action: Hemodialysis tubes provide access through the vein or artery. The tube is thin and flexible and goes into a big vein near the center of the body. There are two openings in the tube. One opening takes out the blood and sends it to a machine that cleans it. The other opening puts the clean blood back into the body. This tube is used when someone needs to have their blood cleaned right away, and they can't use a different kind of tube. This tube is only used for a short time.

Cleaning (Sterilization) Information: Contents are clean and will not cause fever in unopened, undamaged package. Sterilized by Ethylene Oxide.

Accessories Intended for Use in Combination with the Device:

Name of Accessory Description of Accessory
Guidewire Acts as a path for other components.
Guidewire Advancer Helps guidewire introduction.
Introducer Needle Placed into the target vein to gain access.
Scalpel A cutting device.
Dilator Used to make the opening of a vessel larger.
End Cap To keep the catheter clean between treatments.
Syringe Helps get blood return once the needle punctures the vein.

4. Risks and Warnings

If you think something is wrong with how you feel after using the device or you're worried about any problems, talk to your healthcare professional. Remember, this information is not meant to take the place of talking to your doctor if you need to.

How Potential Risks Have Been Controlled or Managed

  • There have been 1,204,381 devices sold since January 2019. There are side effects and risks associated with the device. These include:
  • Infection
  • Bleeding
  • Tube Removal
  • Tube Replacement These risks are reduced to an acceptable level. The labeling describes the risks. The benefit of the device is access for hemodialysis when alternatives are not suitable. These benefits outweigh the risks. The Duo-Flow® Side x Side catheter is associated with risks. These include:
  • Procedural Delays
  • Blood clots in veins (Thrombosis)
  • Infections
  • Punctures in organs (Perforations)
  • Air bubbles in veins (Embolism)
  • Heart problems (Cardiac Event)
  • Feeling unhappy with the procedure (Dissatisfaction)
  • Remaining Risks and Undesirable Effects

  • The Duo-Flow® Side x Side catheter is associated with risks. These include:
  • Procedural Delays
  • Blood clots in veins (Thrombosis)
  • Infections
  • Punctures in organs (Perforations)
  • Air bubbles in veins (Embolism)
  • Heart problems (Cardiac Event)
  • Feeling unhappy with the procedure (Dissatisfaction) The risks of using the Medcomp device are similar to other dialysis tubes. The most common problem is getting an infection. Infections can happen when someone has surgery or stays in the hospital. Infections are not always caused by use of the device. The below tables includes events that can happen when the tube is put in, used, or taken out. Not all device problems are reported.
  • Quantification of Residual Risks
    PMS Complaints 01 January 2019 – 31 December 2023 PMCF Events
    Units Sold: 1,204,381 Units Studied: 94
    Patient Residual Harm Category # of Cases Per Event # of Cases Per Event
    Allergic Reaction Not Reported. Not Reported.
    Bleeding 1 Event in 1,200,000 Cases. Not Reported.
    Cardiac Event Not Reported. Not Reported.
    Embolism Not Reported. Not Reported.
    Infection 1 Event in 300,000 Cases. 1 Event in 30 Cases.
    Perforation Not Reported. Not Reported.
    Stenosis 1 Event in 1,200,000 Cases. Not Reported.
    Tissue Injury Not Reported. Not Reported.
    Thrombosis Not Reported. 1 Event in 90 Cases.

    Warnings and Precautions

  • The below are warnings, precautions, or measures to be taken by patient:
  • To keep germs away from the catheter, wear a mask over your nose and mouth every time the catheter is used.
  • Keep the catheter dressing clean and dry. The dressing should be changed by a medical professional at each dialysis session.
  • Avoid getting the catheter or catheter site wet. Moisture near the catheter site can cause infection.
  • Ask the doctor to explain the signs and symptoms of catheter infection.
  • Never remove the cap at the end of the catheter. The cap and clamps of the catheter must be kept closed when not being used for dialysis.
  • Summary of Any Field Safety Correction Action (FSCA)

    There were no recalls for the device between 01 January 2023 to 31 December 2023.

    5. Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

    Clinical Background of Device

    The Duo-Flow® Side x Side catheter has been available since 1997. The CE Mark was received in November 1997. US FDA clearance was in April 2020. All models included are planned for distribution in the European Union.

    Clinical Evidence for CE-Marking

    The clinical literature review identified 1 article relating to the safety and/or performance of the subject device when used as intended. These articles included approximately 67 cases. Three patient level data activities received information on 94 catheters. 1 user surveys have been received relating to this device. Findings from the clinical literature and data activities support the performance of the subject device. All data on the Duo-Flow® Side x Side catheter has been evaluated. When you use the device as intended, the good things it does are more than the bad things it might cause. This device helps people who have kidney problems get hemodialysis when other treatments are not right for them.

    Safety

  • There is sufficient data to prove conformity to the applicable requirements. The device is safe and performs as intended and claimed by Medcomp. The device is state of the art for allowing short-term vascular access for hemodialysis in adult patients. Medcomp has reviewed:
  • Post-Market Data
  • Medcomp Information Materials
  • Risk Management Documentation The device's risks are displayed clearly and are acceptable for this type of product. Compared to the good things the device does, the risks are okay. There were 139 complaints for 1,204,381 units sold from 01 January 2019 to 31 December 2023. The complaint rate is 0.012%.
  • 6. Possible Therapeutic Alternatives

    When considering alternative treatments, it is recommended to contact your healthcare professional who can consider your individual situation. The Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 clinical practice guidelines have been used to support the below recommendations for treatments.

    Therapy Benefits Disadvantages Key Risks
    • AV Fistula
    • Permanent solution.
    • Lower complication rate than catheter.
    • Requires time.
    • Patients must sometimes self-needle stick.
    • Narrowing of a vein (Stenosis)
    • Thrombosis
    • Bulge in a blood vessel (Aneurysm)
    • High blood pressure in the lungs (Pulmonary hypertension)
    • Lack of blood flow to an area (Steal Syndrome)
    • Blood infection (Septicemia)
    • Hemodialysis Catheter
    • Useful for quick access.
    • Can be used as a bridge between therapies.
    • Not permanent.
    • Catheter dysfunction can happen.
    • Benefit may not be the same for everyone.
    • Post-procedural bleeding
    • Infection
    • Thrombosis
    • Decreased blood flow in dysfunctional catheter
    • Cardiovascular events
    • Fibrin sheath formation around catheter
    • Septicemia
    • Peritoneal Dialysis
    • Less restrictive diet than hemodialysis.
    • Does not require hospitalization.
    • Clearance of impurities is limited by flow and space.
    • Infection of the abdomen (Peritonitis)
    • Septicemia
    • Fluid overload
    • Kidney Transplant
    • Better quality of life.
    • Lower risk of death.
    • Fewer food restrictions.
    • Requires a donor.
    • More risky for certain groups.
    • Patient must take medication for life.
    • Medication has side effects.
    • Thrombosis
    • Severe bleeding (Hemorrhage)
    • Blockage of the tubes that carry urine (Ureteral blockage)
    • Infection
    • Organ rejection
    • Death
    • Heart problem (Myocardial infarction)
    • Blocked blood flow to brain (Stroke)
    • Comprehensive Conservative Care
    • Less imposed symptom burden.
    • Preserves life satisfaction.
    • May aggravate clinical condition.
    • Not designed to treat.
    • Treatment may not actually minimize risks associated with CKD.

    7. Suggested Profile and Training for Users

    The catheter should be inserted, manipulated, and removed by a qualified, licensed physician or other qualified health care professional under the direction of a physician.

    Acronyms

    Abbreviation Definition
    AKI Acute Kidney Injury
    AV Arteriovenous
    CE Conformité Européenne (European Conformity)
    CKD Chronic Kidney Disease
    cm centimeter
    CMR Carcinogenic, mutagenic, reprotoxic
    CVC Central Venous Catheter
    EU European Union
    F French (thickness of catheter)
    FDA Food and Drug Administration
    FSCA Field Safety Corrective Action
    HD Hemodialysis
    KDOQI Kidney Disease Outcomes Quality Initiative
    PA Pennsylvania
    PMCF Post Market clinical follow-up
    PMS Post Market Surveillance
    SSCP Summary of Safety and Clinical Performance
    STHD Short-term Hemodialysis
    USA United States of America
    w/w Weight over Weight

    Version 5.00 of Medical Components, Inc. Template QA-CL-200-1