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

Model Number	8888423103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, the patient underwent peritoneal dialysis catheter placement on (b)(6) 2025.Intraoperative and postoperative examinations revealed no leaks in the peritoneal dialysis catheter.On the day of the event, at 9:00 am, during the dressing change of the abdominal surgical site, a leak was observed at the titanium connector of the peritoneal dialysis catheter approximately 0.5 cm from the connection point.This leak posed a risk of severe infections such as peritonitis and could compromise dialysis efficacy.Immediate measures included clamping the tunnel exit of the peritoneal catheter with a blue clamp, followed by antiseptic flushing with povidone-iodine solution.The titanium connector and the short peritoneal dialysis catheter were replaced.The patient was administered oral levofloxacin for three days for infection prophylaxis.Routine analysis and culture of the peritoneal dialysis effluent were performed, with no signs of fever, abdominal pain, or other discomfort observed.A crack was observed at the luer adapter.Tego was not utilized.The insertion site was not treated prior to product placement.As a remedial action, the catheter was repaired.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.

• Brand Name: ARGYLE
• Common Device Name: 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: 22284216
• Report Number: 1282497-2025-00421
• Device Sequence Number: 8310048
• Product Code: FJS
• UDI-Device Identifier: 10884521055933
• UDI-Public: 10884521055933
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888423103
• Device Catalogue Number: 8888423103
• Device Lot Number: 2302500167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 03/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Unknown