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	Insufficient Information (4580)
Date of Event	04/07/2024
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, after the surgery, the patient underwent long-term peritoneal dialysis at home.On (b)(6) 2024, leakage from the peritoneal dialysis catheter was discovered, resulting in hospitalization.The initial judgement was that it was caused by wear of the catheter.There was no titanium connector issue.The patient admitted to the hospital related to this reported event on (b)(6), 2024.It was also stated that the cause of the event was that there might be repeated folding during operations, resulting in repeated friction between the catheter and the titanium connector.Flushing was done prior to use and the result was normal.Nothing unusual observed on the device prior to use.No other products being utilized with the device.No other defects/damages found on the product.The cleaning agent was not allowed to dry thoroughly prior to applying ointment(s) to the area.The cleaning agent never switched over the life of the catheter.The cleaning agents never mixed.The patient was not responsible for any type of catheter maintenance.The site never used sepsiderm to clean catheters.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheters.No ointment utilized at the exit site.The wound dressing(s) did not include any cleaning agents or antimicrobial properties.They cut off the cracked part and they reconnected the catheter and titanium connector as preliminary action on the same day.No repair kit used.Once the repair of the catheter and titanium connector was completed, the dialysis treatment proceeded and completed.The patient's status at the resolution of the event was good.

• 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: 19442760
• Report Number: 1282497-2024-00147
• Device Sequence Number: 12553937
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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 Expiration Date: 02/05/2026
• Device Model Number: 8888423103
• Device Catalogue Number: 8888423103
• Device Lot Number: 2034400193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 06/01/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 64 KG