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

Model Number	8888425710
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter during treatment, around eight months after the catheter was implanted, the catheter was found with a hole on the inside of the abdomen, which not caused by external factors.There was a leak, and there were no other damages found on the product where the leak was observed.There were no other products being utilized with the device, and no excessive force was used.Ointments were not used at the exit site; compresses were the wound dressing being utilized, which did not include any cleaning agents or antimicrobial properties.The patient was responsible for the maintenance of the catheter by changing the dressing regularly.There were no cleaning agents or antibiotics that the patient used themselves on the catheters.It was also stated that the hole was in the subcutaneous area of the catheter and could not be repaired.As a result, the patient had to undergo surgery and was admitted ed for an inpatient stay from (b)(6)2024 to (b)(6)2024 (eight days).The catheter was explanted, and a new catheter with a different lot and product id was inserted on the same day.Since the patient was unable to start peritoneal dialysis immediately, a tunneled atrial catheter was also inserted.Hemodialysis was temporarily carried out until the wound had healed.Due to the event, the patient experienced fluid retention along the catheter tunnel during peritoneal dialysis.There was no blood loss.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 correction: b2, b5, e1 (region), e4 (email), g2 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted large tissue growth towards the proximal end of the cuff, though no abnormalities were observed during the first inspection.Functionally, the catheter was flushed and clamped, and a pinhole leak appeared towards the distal end of the cuff.It was reported that the catheter shaft had a hole and leak.The reported issue was 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.
Event or Problem Description
According to the reporter, during treatment, around eight months after the catheter was implanted, the catheter was found with a hole on the inside of the abdomen, which was not caused by external factors.There was a leak, and there were no other damages found on the product where the leak was observed.There were no other products being utilized with the device, and no excessive force was used.Ointments were not used at the exit site; compresses were the wound dressing being utilized, which did not include any cleaning agents or antimicrobial properties.The patient was responsible for the maintenance of the catheter by changing the dressing regularly.There were no cleaning agents or antibiotics that the patient used themselves on the catheters.It was also stated that the hole was in the subcutaneous area of the catheter and could not be repaired.As a result, the patient had to undergo surgery and was admitted for an inpatient stay from (b)(6)2024 (eight days).The catheter was explanted, and a new catheter with a different lot and product id was inserted on the same day.Since the patient was unable to start peritoneal dialysis immediately, a tunneled atrial catheter was also inserted.Hemodialysis was temporarily carried out until the wound had healed.Due to the event, the patient experienced fluid retention along the catheter tunnel during peritoneal dialysis.There was no blood loss.

• 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: 21129901
• Report Number: 1282497-2025-00017
• Device Sequence Number: 17848746
• Product Code: FJS
• UDI-Device Identifier: 10884521056022
• UDI-Public: 10884521056022
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K813488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 8888425710
• Device Catalogue Number: 8888425710
• Device Lot Number: 2119400160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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; Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 73 KG