Summary of Safety and Clinical Performance

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. This SSCP is not intended to replace the Instructions for Use as the main document to ensure the safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users or patients.

Applicable Documents

1. Device Identification and General Information

Device Trade Name(s): Canaud Catheters

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

Manufacturer Single Registration Number (SRN): US-MF-000008230

Basic UDI-DI: 00884908283NH

Medical Device Nomenclature: F900202 – Permanent Hemodialysis Catheter and Kits

Class of Device: III

Date First CE Certificate Issued: Nov-93

Authorized Representative Name and SRN: European Regulatory Expert Medical Product Service GmbH (MPS) Borngasse 20 35619 Braunfels, Germany SRN: DE-AR-000005009

Notified Body Name and Single Identification Number: BSI Netherlands NB2797

Device Grouping and Variants

The devices in scope of this document are all long-term hemodialysis catheter sets. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section “Accessories intended for use in combination with the Device”).

Variant Devices:

Procedure Trays:

Configurations of Procedure Trays:

2. Intended Use of the Device

Intended Purpose: As per product IFU (IFU 40777-1BSI), Canaud Catheters are intended for use in adult patients who do not have functional permanent vascular access or are not candidates for permanent vascular access for whom central venous vascular access for 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. The catheter is single use only.

Indication(s): As per product IFU (IFU 40777-1BSI), the Canaud Catheters are indicated for short-term or long-term use where vascular access is required for 14 days or more for the purpose of hemodialysis.

Target Population(s): Canaud Catheters are intended for use in adult patients who do not have functional permanent vascular access or are not candidates for permanent vascular access for whom central venous vascular access for 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:

• As per product IFU (IFU 40777-1BSI), the Canaud catheters are contraindicated as follows:
• 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 Name: Canaud Catheters

Description of Device: The Canaud Catheter is a long-term single lumen catheter. Two catheters are inserted into the target vein that are used to remove and return blood through two separate passages (lumens). The subcutaneous portion of the adapter has a barbed stem for attachment to the subcutaneous lumen. A suture, attached to each adapter, is used to anchor the catheter within the tunnel. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter has been tested at flow rates of up to 500 mL/min.

Device Name: Canaud Catheters

Description of Device: The Canaud Catheter is a long-term single lumen catheter. Two catheters are inserted into the target vein that are used to remove and return blood through two separate passages (lumens). The subcutaneous portion of the adapter has a barbed stem for attachment to the subcutaneous lumen. A suture, attached to each adapter, is used to anchor the catheter within the tunnel. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter has been tested at flow rates of up to 500 mL/min.

Materials / Substances in Contact with Patient Tissue:

The percentages below are based on the weight of the Canaud catheter (7.415g).

The percentages below are based on the weight of the Canaud catheter (7.415g).

Note:Per the instructions for use, the device is contraindicated for patients with known or suspected allergies to the above materials.

Note:Accessories containing stainless steel may contain up to 4% weight of the CMR substance cobalt.

Information on Medicinal Substances in the Device:

How the Device Achieves its Intended Mode of Action: Hemodialysis catheters are centrally placed access tubes. A typical hemodialysis catheter uses a thin, flexible tube. This catheter has two separate tubes. The tubes go into a large vein. The vein is usually the internal jugular vein. Blood withdraws through one tube of the catheter. The blood flows to the dialysis machine through a separate tubing set. The blood is then processed and filtered. The blood returns to the patient through the second tube. This device is used when dialysis must start at once. Patients may not have a functioning AV fistula or graft. Catheter hemodialysis normally happens on a short-term basis. Long-term access may occur in some cases. For example, when there are problems supporting an AV fistula or graft.

Sterilization Information: Contents sterile and non-pyrogenic in unopened, undamaged package. Sterilized by Ethylene Oxide.

Previous Generations / Variants:

Accessories Intended for Use in Combination with the Device:

Other Devices or Products Intended for Use in Combination with the Device:

4. Risks and Warnings

Residual Risks and Undesirable Effects: All surgical procedures carry risk. Medcomp has implemented risk management processes to proactively find and mitigate these risks as far as possible without adversely affecting the benefit-risk profile of the device. After mitigation, residual risks and the possibility of adverse events from use of this product remain. Medcomp has determined that all residual risks are acceptable.

Warnings and Precautions:

All warnings have been reviewed against the risk analysis, PMS, and usability testing to validate consistency between the sources of information.

• Do not insert catheter in thrombosed vessels.
• Do not advance the guidewire or catheter if unusual resistance is encountered.
• Do not not insert or withdraw the guidewire forcibly from any component. If the guidewire becomes damaged, guidewire and any associated componentry must be removed together.
• Do not resterilize the catheter or accessories by any method.
• Contents sterile and non-pyrogenic in unopened, undamaged package. STERILIZED BY ETHYLENE OXIDE
• Do not re-use catheter or accessories as there may be a failure to adequately clean and decontaminate the device which may lead to contamination, catheter degradation, device fatigue, or endotoxin reaction.
• Do not use catheter or accessories if package is opened or damaged.
• Do not use catheter or accessories if any sign of product damage is visible or the use-by date has passed.
• Do not use sharp instruments near the extension tubing or catheter lumen.
• Do not use scissors to remove dressing.
• Do not use iodine products for site care with this silicone catheter. Precautions listed in the Canaud Catheters IFU are as follows:
• Examine catheter lumen and extensions before and after each treatment for damage.
• To prevent accidents, assure the security of all caps and bloodline connections prior to and between treatments.
• Use only Luer Lock (threaded) Connectors with this catheter.
• In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.
• Before attempting catheter insertion, ensure that you are familiar with the potential complications and their emergency treatment should any of them occur.
• Repeated overtightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure.
• The catheter will be damaged if clamps other than what is provided with this kit are used.
• Avoid clamping near the Luer Lock and hub of the catheter. Clamping of the tubing repeatedly in the same location may weaken tubing.
• Use only Medcomp® Canuad Adapters with this catheter. When cutting catheter to desired length, assure the lumen is cut square and that the remaining catheter lumen is not damaged. Additional warnings and cautions listed in the Canaud Catheter IFUs are as follows:
• Physician discretion is strongly advised when inserting this catheter in patients who are unable to take or hold a deep breath.
• Patients requiring ventilator support are at increased risk of pneumothorax during subclavian vein cannulation, which may cause complications.
• Extended use of the subclavian vein may be associated with subclavian vein stenosis.
• The length of the wire inserted is determined by the size of the patient. Monitor patient for arrhythmia throughout this procedure. The patient should be placed on a cardiac monitor during this procedure. Cardiac arrhythmias may result if guidewire is allowed to pass into the right atrium. The guidewire should be held securely during this procedure. The length of the wire inserted is determined by the size of the patient. Monitor patient for arrhythmia throughout this procedure. The patient should be placed on a cardiac monitor during this procedure. Cardiac arrhythmias may result if guidewire is allowed to pass into the right atrium. The guidewire should be held securely during this procedure.
• DO NOT grasp and pull the guidewire prior to releasing the J-Straightener. Damage to the guidewire may occur if it is pulled against the restraint of the J- Straightener.
• DO NOT bend sheath/dilator during insertion as bending will cause the sheath to prematurely tear. Hold sheath/dilator close to the tip (approximately 3cm from tip) when initially inserting through the skin surface. To progress the sheath/dilator towards the vein, regrasp the sheath/dilator a few centimeters (approximately 5cm) above the original grasp location and push down on the sheath/dilator. Repeat procedure until sheath/dilator is fully inserted.
• Never leave sheath in place as an indwelling catheter. Damage to the vein will occur.
• Do not tunnel through muscle.
• Use extreme care during assembly of the extension adapter to the lumen in order to avoid damaging the lumen.
• Assure that all air has been aspirated from the catheter and extensions. Failure to do so may result in air embolism.
• Do not turn the adapter and/or compression plug more than one half turn as lumen may kink resulting in poor blood flow.
• Failure to verify catheter placement may result in serious trauma or fatal complications.
• Only clamp catheter with in-line clamps provided.
• Extension clamps should only be open for aspiration, flushing, and dialysis treatment.
• Always review hospital or unit protocol, potential complications and their treatment, warnings, and precautions prior to undertaking any type of mechanical or chemical intervention in response to catheter performance problems.
• Only a physician familiar with the appropriate techniques should attempt the following procedures (Catheter Lock, Catheter Removal)
• Due to risk of exposure to HIV or other blood borne pathogens, health care professionals should always use Universal Blood and Body Fluid Precautions in the care of all patients.
• Always review hospital or unit protocol, potential complications and their treatment, warnings, and precautions prior to catheter removal.
• When removing the catheter, DO NOT use a sharp, jerking motion or undue force; this may tear the catheter. Free the lumen from the tissue prior to removal.

Other Relevant Aspects of Safety: For a period of 01 January 2020 to 31 March 2025 there were 51 complaints for 28,740 units sold, giving an overall complaint rate of 0.18%. There were no death-related events. No events resulted in recalls during the review period.

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

Summary of Clinical Data Related to Subject Device

Clinical performance was measured using parameters including but not limited to dwell time, catheter insertion outcomes, and adverse event rates. Critical clinical parameters extracted from these studies met standards set forth in the guidelines for the State of the Art. There were no unforeseen adverse events or other high occurrences of adverse events detected in any of the clinical activities. Medcomp® catheters are subjected to, and must pass, simulated use testing intended to replicate use 3 times per week for 12 months as part of device development. The Canaud Catheter passed this testing. Although Medcomp® catheters contain no materials which degrade over time, fully functional catheters may be removed for other reasons, such as intractable infection, change of therapy (such as Renal replacement (transplant) or use of an arterio-venous graft/fistula). Published clinical literature does not always focus on the physical lifetime of a catheter for these reasons. In the case of the Canaud Catheter, 738 catheters had a 14.2 month [Range: 3 months – 10 years] duration of use that has been found in clinical use reported to date. Based on this information, the Canaud Catheter has a 12-month lifetime; however, the decision to remove and/or replace the catheter should be based on clinical performance and need, and not any predetermined point in time.

Summary of Clinical Data Related to the Equivalent Device

An equivalent device was not used for the device’s clinical evaluation.

Summary of Clinical Data from Pre-Market Investigations (if applicable)

No pre-market clinical devices were used for the device’s clinical evaluation.

Summary of Clinical Data from Other Sources

Source:Summary of Published Literature

Summary: Clinical evidence literature searches have found fourteen published literature articles representing 404 Canaud device family specific cases and an additional 2,968 mixed cohort cases inclusive of the Canaud device family. The articles include one randomized controlled trial (Klouche et al., 2007), five prospective studies (Jean et al., 2001, Karaaslan et al., 2001, Canaud et al., 2002, Lemaire et al., 2009, Heng et al., 2011), four retrospective studies (Jean et al., 2009, Beaussart et al., 2012, Canaud et al., 2023, Canaud et al., 2023), and four uncontrolled studies (Canaud et al., 1998, Leblanc et al., 1998, Cardelli et al., 1998, Cardelli et al., 2001). Bibliography: Beaussart H, Décaudin B, Résibois JP, Odou P, Azar R. Tunneled hemodialysis catheters complications: A retrospective and monocentric comparative study of two devices. Nephrologie et Therapeutique. 2012;8(2):101-105. Canaud B, Leray-Moragues H, Garrigues V, Mion C. Permanent twin catheter: A vascular access option of choice for haemodialysis in elderly patients. Nephrology Dialysis Transplantation. 1998;13(SUPPL. 7):82-88. Canaud B, Leray-Moragues H, Kerkeni N, Bosc JY, Martin K. Effective flow performances and dialysis doses delivered with permanent catheters: A 24-month comparative study of permanent catheters versus arterio-venous vascular accesses. Nephrology Dialysis Transplantation. 2002;17(7):1286-1292. Canaud, B., Leray-Moragues, H., Chenine, L., Morena, M., Miller, G., Canaud, L., & Cristol, J. P. (2023). Comparative Clinical Performances of Tunneled Central Venous Catheters versus Arterio-Venous Accesses in Patients Receiving High-Volume Hemodiafiltration: The Case for High-Flow DualCath, a Tunneled Two-Single-Lumen Silicone Catheter. Journal of Clinical Medicine, 12(14), 4732. Canaud, B., Leray-Moragues, H., Klouche, K., Morena, M., Chenine, L., Miller, G., & Canaud, L. (2023). Percutaneous Placement and Management of High-flow Catheter for Hemodialysis: The Case for DualCath, Two-tunneled, Single-lumen Silicone Catheters. Indian Journal of Vascular and Endovascular Surgery, 10(4), 270-275.Cardelli R, D'Amicone M, Gurioli L, et al. Permanent vascular catheters for extracorporeal dialysis. Preliminary study: Canaud and Tesio catheters. Minerva urologica e nefrologica = The Italian journal of urology and nephrology. 1998;50(1):51-54. Cardelli R, D'Amicone M, Stramignoni E, et al. Canaud central venous catheters: 4-year experience. Minerva urologica e nefrologica = The Italian journal of urology and nephrology. 2001;53(3):139-143. Heng AE, Abdelkader MH, Diaconita M, et al. Impact of short term use of interdialytic 60% ethanol lock solution on tunneled silicone catheter dysfunction. Clinical Nephrology. 2011;75(6):534-541. Jean G, Charra B, Chazot C, Vanel T, Terrat JC, Hurot JM. Long-term outcome of permanent hemodialysis catheters: A controlled study. Blood Purification. 2001;19(4):401-407. Jean G, Vanel T, Bresson É, et al. Une stratégie efficace pour diminuer l’utilisation et les complications des cathéters veineux centraux tunnelisés en hémodialyse. Néphrologie & Thérapeutique. 2009;5(4):280-6. Karaaslan H, Peyronnet P, Benevent D, Lagarde C, Rince M, Leroux-Robert C. Risk of heparin lock-related bleeding when using indwelling venous catheter in haemodialysis. Nephrology Dialysis Transplantation. 2001;16(10):2072-2074. Klouche K, Amigues L, Deleuze S, Beraud JJ, Canaud B. Complications, Effects on Dialysis Dose, and Survival of Tunneled Femoral Dialysis Catheters in Acute Renal Failure. American Journal of Kidney Diseases. 2007;49(1):99-108. Leblanc M, Bosc JY, Vaussenat F, Maurice F, Leray-Moragues H, Canaud B. Effective blood flow and recirculation rates in internal jugular vein twin catheters: Measurement by ultrasound velocity dilution. American Journal of Kidney Diseases. 1998;31(1):87-92. Lemaire X, Morena M, Leray-Moragués H, et al. Analysis of risk factors for catheter-related bacteremia in 2000 permanent dual catheters for hemodialysis. Blood Purif. 2009;28(1):21-28.

• Source:PMCF_LTHD_212

The Fichier Canaud database was acquired from Hemotech on 11 February 2020. Catheter placements include those done by Prof. Bernard Canaud at the Montpellier University Hospital. This database was updated during the data collection period 10 October 1990 – 26 March 2012. Real-world performance data on the use of Medcomp Canaud catheters was measured against acceptance criteria derived from State of the Art safety and performance outcome measures from published literature. The 1028 cases used for analysis exceeded the sample size determination of 89 described in PMCF_LTHD_212_Protocol. The following outcome measures were confirmed to be within State of the Art safety and performance outcome measures from published literature for Medcomp Canaud long-term hemodialysis catheters:

• Source:PMCF_Medcomp_211

The Medcomp User Survey acquired responses from healthcare personnel familiar with any number of Medcomp’s product offerings. 28 respondents responded that they or their facility have used Medcomp long-term hemodialysis catheters, with 0 of those respondents using the Canaud device. There were no differences in mean user sentiments within long-term hemodialysis catheters across State of the Art Performance and Safety Outcome Measures or between device types relating to safety or performance. The following data points were collected from users of Medcomp long-term hemodialysis catheters (n=28):

Overall Summary of Clinical Safety and Performance

Upon review of the Canaud Catheter data across all sources, it is possible to conclude that the benefits of the subject device, which is facilitating hemodialysis in patients in whom other therapies or conservative care are not indicated or desirable as determined by the physician, outweigh the overall and individual risks when the device is used as intended by the manufacturer. It is the manufacturer’s and clinical expert evaluator’s opinion that activities both complete and ongoing are sufficient to support the safety, efficacy, and acceptable benefit/risk profile of the Canaud catheters.

On-going or Planned Post-Market Clinical Follow-Up (PMCF)

No emerging risks, complications or unexpected device failures have been detected from PMCF activities.

6. Possible Therapeutic Alternatives

The Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 clinical practice guidelines have been used to support the below recommendations for treatments.

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. In certain circumstances, patients who may be suitable for home hemodialysis may manipulate the external connections of the catheter. As per guidelines stated from the International Society of Hemodialysis, if home dialysis is recommended, each patient will undergo a thorough training in order to obtain optimal results from home dialysis treatments. The objectives of the training program are to (1) provide the appropriate amount of information to ensure that the patient will be able to dialyze safely at home; (2) enable the patient to monitor and manage other elements of his or her chronic kidney disease, such as obtaining samples for lab work and maintaining appropriate nutrition and diet; and (3) help the patient and his or her care partner(s) cope with barriers and fears associated with home HD During training, the patient will also receive technical education on the operations and maintenance of the water treatment system. During training, the ideal nurse trainer-to-patient ratio is typically 1:1. An idealized schedule of training is created, with weekly areas of focus and training objectives. In practice, however, training is individualized to address any identified learning barriers or risks for failure.

8. Reference to Any Harmonized Standards and Common Specifications (CS) Applied

Revision History