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

Model Number	8888423103
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
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, on (b)(6) 2023, the patient was admitted to the hospital as an outpatient due to elevated creatinine for 7 years, worsening with general fatigue for 20 days.On (b)(6) 2023, peritoneal dialysis abdominal cavity catheterization was performed under local anesthesia, and the patient was discharged on (b)(6) 2024.It was stated that after discharge, the patient received the peritoneal dialysis treatment at home.On the day of the event, during dialysis, fluid leakage was found in the peritoneal dialysis catheter and accessories at the titanium connector.On (b)(6) 2024, the patient came to the hospital to see a doctor for treatment.The titanium connector was removed, cut off a part of the short tube that leaked fluid, and reconnected it after disinfection.No adverse consequences occurred.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: 20382947
• Report Number: 1282497-2024-00431
• Device Sequence Number: 12748724
• 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: 2023
• 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
• Report Date (Section B): 10/07/2024

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 Expiration Date: 09/09/2025
• Device Model Number: 8888423103
• Device Catalogue Number: 8888423103
• Device Lot Number: 2019500238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/07/2024
• Date Device Manufactured: 10/17/2020
• 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: 51 YR
• Patient Sex: Male