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

Model Number	8888413823
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during insertion procedure, a piece which was clear plastic ring of the pd (peritoneal dialysis) catheter broke off.The catheter was not repaired.There was no leak.There was no luer adapter issue.The insertion site was treated prior to product placement.Nothing unusual observed on the device prior to use.It was soaked in normal saline.No other products being utilized with the device.No cleaning agent used on the device.No other defects/damages found on the product.The insertion site was prepped with hibiclens prior to product placement.The product was never implanted.Physician was able to remove pieces immediately via laparoscopic grasper and replace it with a new pd catheter.The procedure was completed after resolving the issue.There was no blood loss.Blood transfusion was not required.No medical intervention/medical treatment required as the result of the event.The patient treated under general anesthesia and the anesthesia time was not extended by greater than 30 minutes.There was no reported patient 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.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 insertion procedure, a piece which was clear plastic ring of the pd (peritoneal dialysis) catheter broke off.The catheter was not repaired.There was no leak.There was no luer adapter issue.The insertion site was treated prior to product placement.Nothing unusual observed on the device prior to use.It was soaked in normal saline.The result of flushing prior to use was normal.No other products being utilized with the device.No cleaning agent used on the device.No other defects/damages found on the product.The insertion site was prepped with hibiclens prior to product placement.The product was never implanted.Physician was able to remove pieces immediately via laparoscopic grasper and replace it with a new pd catheter.The procedure was completed after resolving the issue.There was no blood loss.Blood transfusion was not required.No medical intervention/medical treatment required as the result of the event.The patient treated under general anesthesia and the anesthesia time was not extended by greater than 30 minutes.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3 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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was a hole, break, crack or leak on the catheter shaft.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.

• 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: 19387902
• Report Number: 1282497-2024-00133
• Device Sequence Number: 4071550
• Product Code: FJS
• UDI-Device Identifier: 10884521004634
• UDI-Public: 10884521004634
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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 Model Number: 8888413823
• Device Catalogue Number: 8888413823
• Device Lot Number: 2318800102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 08/15/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/28/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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
• Patient Sex: Unknown