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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, after dialysis, the pd (peritoneal dialysis) catheter had a crack/hole/tear in the tube, and there was a leak located at the catheter shaft.The cleaning agents used on the device were vancomycin and ceftazidime.A tego was not utilized, and there was no luer adapter issue.The clinical consequence required repairing the defective catheter by cleanly cutting it off, replacing the connection screw and transfer system, and providing prophylactic care for peritonitis with vancomycin and ceftazidime.The broken catheter tube was connected together with a competitor's luer-lock connection.The personal injury involved abdominal emptying.
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, after dialysis, the pd (peritoneal dialysis) catheter had a crack/hole/tear in the tube, and there was a leak located at the catheter shaft.A tego was not utilized, and there was no luer adapter issue.The catheter had been in place for 2 years and 8 months.Flushing was not done prior to use.No other products were being utilized with the device.Nothing unusual was observed on the device prior to use.No other defects or damages were found on the product.Only octenisept was used as a standard cleaning agent.The exit was cleaned with a sterile compress and octenisept and covered with a sterile porexix plaster.After cleaning, the exit was dried thoroughly with sterile compresses.Sepsiderm was not used in the center, and there had been no protocol changes for cleaning agents used recently.Vancomycin and ceftazidime were not used as cleansing agents but as therapy prophylaxis against peritonitis.The patient themselves did not use any antibiotics on the catheter.The clinical consequence required repairing the defective catheter by cleanly cutting it off, replacing the connection screw and transfer system, and providing prophylactic care for peritonitis with vancomycin and ceftazidime.Only vancomycin and ceftacidime were administered to prevent peritonitis; otherwise, no other medication was given.The broken catheter tube was connected together with a competitor's luer-lock connection.The report noted an injury involving abdominal emptying, which occurred due to a leak in the pd catheter, causing fluid to leak out of the abdomen.There were no pre-existing conditions or diseases that could have caused the fluid to leak out of the abdomen or affected a tear/hole in the pd catheter.There was no blood loss, and no blood transfusion was required.The patient, being on dialysis, seemed to be okay at the resolution of the event.
Additional Manufacturer Narrative
Additional information: a2, a3b, a4, b5, d6a, d9, g3, h3, h6.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
Correction: d4(unique identifier (udi) #) additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the cannula had a leak, and there was a cut in the catheter where it met the adapter.It was reported that there was a hole, break, crack, or leak on the catheter shaft.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur from clamping the tubing too close to the adapter, which causes excess stress on the tubing and can lead to breaks or leaks in the tubing where it connects to the adapter.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: clamping the catheter repeatedly in the same spot could weaken the tubing: change the position of the clamp regularly to prolong the life of the tubing.Avoid clamping near the adapter.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: 22044684
• Report Number: 1282497-2025-00331
• Device Sequence Number: 8908603
• Product Code: FJS
• UDI-Device Identifier: 10884521004085
• UDI-Public: (01)10884521004085(17)261115(10)2131200215
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2025

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: 2131200215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 08/14/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2021
• 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
• Patient Age: 46 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG