MAUDE Adverse Event Report: COVIDIEN LLC ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888413419

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

According to the reporter, they called the peritoneal dialysis department from a patient followed from home concerning a leak in the peritoneal dialysis catheter because the patient found the bed "all wet" on at 9am.They asked the patient to come in for a consultation to check the problem and repair the catheter if necessary, bearing in mind that patient was living more than 1 hour from the hospital.When the patient arrived, first had to remove the tape wrapped around the catheter, which had been used to seal the hole and also rolled it up under a bandage so that it would not wander out of clothes.The patient showed roughly where the hole was.Once the plaster had been removed, the hole could be seen at the end of the grey tip which was a part of the catheter and which connected to the extension line.It would appear that the cut was due to the rigidity of the adapter tip, which had damaged the catheter tubing when it was being handled (possible twisting).This event had the following consequences: major risk of infection, with hospital treatment due to the impossibility of using the catheter as it was and therefore the following: cytology on the dialysate present in the peritoneal cavity since the morning exchange at home, complete drainage of the peritoneal cavity, sectioning of the catheter after the grey catheter adapter and fitting of a titanium adapter and ring, as well as a new extension line, administration of a loading dose antibiotic therapy protocol in the new new dialysate infused into the patient.The catheter has been removed from the patient and retained.There was no reported patient outcome.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted a portion of one catheter.The cannula had been cut just before the proximal cuff.The distal end of the catheter (including cuffs) was not returned.The end of the returned cannula had a cut where it was attached to the beta cap adapter.It was presumed that the cut in the cannula was not present when the catheter was implanted, therefore the most likely root cause of the leak was damage during use.It was reported that there was a hole, break, crack or leak on the catheter shaft.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ARGYLE
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18664564
• MDR Text Key: 334846020
• Report Number: 3009211636-2024-00060
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888413419
• Device Catalogue Number: 8888413419
• Device Lot Number: 2226300111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1