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

Model Number	8811313010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, on the day of the event, when the nurse was performing the peritoneal dialysis heparin saline flushing for the patient, it was found that the catheter ruptured and leaked water at about 3cm of the front section at the connection between the peritoneal dialysis catheter and the peptide connector.The dialysis catheter was immediately clamped and was reported to the doctor, then replaced the titanium connector and used it normally.The patient had an infection due to the event.
Event or Problem Description
According to the reporter, on the day of the event, when the nurse performed the peritoneal dialysis heparin saline flushing, the catheter ruptured and leaked water at about 3cm from the front section at the connection between the peritoneal dialysis catheter and the peptide connector.There was nothing else unusual observation on the device prior to use.No additional damages were found where the leak occurred, and no excessive force was used on the device.No other products were utilized with the device, and no cleaning agent typically used to clean the device in its entirety.Tego was not utilized, nor was any prescribed or over-the-counter treatment.The patient was not responsible for catheter maintenance and did not use any cleaning agent or antibiotic on the catheter.Sepsiderm was not used.As a remedial action, the dialysis catheter was immediately clamped, reported to the doctor, and replaced the titanium connector, which was then discarded.A repair kit was not used.The treatment was completed after the remedial action.There was no blood loss, and no transfusion was performed.The patient developed an infection due to the event.
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.

• 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: 21028316
• Report Number: 1282497-2024-20058
• Device Sequence Number: 4008153
• Product Code: FJS
• UDI-Device Identifier: 10884521004085
• UDI-Public: 10884521004085
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8811313010
• Device Catalogue Number: 8811313010
• Device Lot Number: 2227200255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/15/2025
• Date Device Manufactured: 03/01/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female