MAUDE Adverse Event Report: MEDCOMP MEDCOMP SPLIT CATH II; CATHETER, HEMODIALYSIS, IMPLANTED

Patient Problems Bacterial Infection (1735); Sepsis (2067); Fungal Infection (2419); Thrombosis/Thrombus (4440); Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Event Description

According to the literature, a retrospective cohort study between 2012 and 2018 was undertaken to determine the infection free survival rate of tunneled cuffed catheters (tcc), the incidence and causes of catheter failure, and the associated risk factors in children undergoing maintenance hemodialysis through tunneled catheters.Forty-five (45) tccs were inserted in patients between the ages of 5 and 16.Either a silicone mahurkar catheter in sizes 8, 10, or 12.5 fr was used or a competitor device.Nine deaths were reported where 3 died due to catheter related blood stream infection (crbsi) associated sepsis and 6 due to causes unrelated to the catheter.Serious complications included infection in 15 patients where the organism of infection was either gram negative bacilli, klebsiella, pseudomonas, mrsa, citrobacter, acinetobacter, or candida glabra.Infections were treated with either antibiotics or catheter removal.Thrombosis occurred in 13 patients.Thrombosis was treated with either urokinase locking solutions, recombinant-urokinase infusions, or catheter removal.Non-serious complications included 2 kinking and malposition of catheters which were either managed with wire manipulation or catheter removal and 3 catheters that were cracked were removed and replaced with another catheter.The authors do not provide information on which reported adverse events are related to mahurkar catheters or a competitor device.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Reference reports: mw5149530, mw5149531, mw5149533.

• Brand Name: MEDCOMP SPLIT CATH II
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDCOMP
• MDR Report Key: 18393557
• MDR Text Key: 331325189
• Report Number: MW5149532
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1