MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN LLC. ARGYLE PERITONEAL DIALYSIS CATHETER KIT; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888413823

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2022

Event Type  malfunction  

Event Description

This malfunction / defect has happened to us at least five times.We know of other facilities that have had similar problems with this device.The argyle peritoneal dialysis catheter has a defect on certain lots where the diameter of the catheter is too large in diameter to pass through the peel-away sheath provided.We used components of a different lot of the same item to challenge this hypothesis and were able to determine that it was the catheter and not the peel-away sheath that was defective.This was an issue as when the sheath is fully inserted into the patients abdomen.This is a crucial point in the procedure where you do not want any delays or problems while attempting to insert the catheter.Fda safety report id # (b)(4).

• Brand Name: ARGYLE PERITONEAL DIALYSIS CATHETER KIT
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): MEDTRONIC / COVIDIEN LLC.
• MDR Report Key: 13506558
• MDR Text Key: 285531064
• Report Number: MW5107359
• Device Sequence Number: 3
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888413823
• Device Catalogue Number: 8888413823
• Device Lot Number: 21133003
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic