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

Model Number	8888411405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
Date of Event	04/25/2024
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.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 examination at the hospital on (b)(6) 2024, there was inadequate drainage, the patient's catheter was examined at the hospital, and it was found that the catheter was seriously displaced.The patient was actively requested to change to hemodialysis and arranged for surgical removal of the catheter.The next day, during removal, on the day of surgery, it was found that the catheter was broken (ruptured) in the abdominal cavity.The catheter was not repaired, and there was a leak.There was no cleaning agent used on the device.There was no luer adapter issue.Flushing was not done prior to use.Nothing unusual was observed on the device prior to use.No other products were utilized with the device.No other defects or damages were found on the product.The site never used sepsiderm to clean the catheter.No ointment(s) were utilized at the exit site.No wound dressing(s) were utilized.It was also stated that laparoscopic surgery was done to resolve the broken catheter in the abdomen.The patient required an x-ray as part of the original procedure for the removal of the catheter.All parts of the catheter were removed, and the procedure was completed.The anesthetic time was not extended by 30 minutes or greater.After the catheter was removed, the patient switched to hemodialysis with other product, and they were able to proceed and complete the treatment.After almost three months when the catheter was implanted, the patient was hospitalized for five days.There was no additional medical intervention required to retrieve the broken portion of the device.No treatment (lotions/ointments, medications) by prescription or over the counter (otc) was used.There was no blood loss, and blood transfusion was not required.The product was replaced.The patient was stable.
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
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 examination at the hospital on (b)(6) 2024, the patient's catheter was examined at the hospital, and it was found that the catheter was seriously displaced.The patient was actively requested to change to hemodialysis and arranged for surgical removal of the catheter.The next day, during removal, on the day of surgery, it was found that the catheter was broken (ruptured) in the abdominal cavity.The catheter was not repaired, and there was a leak.There was no cleaning agent used on the device.There was no luer adapter issue.Flushing was not done prior to use.Nothing unusual was observed on the device prior to use.No other products were utilized with the device.No other defects or damages were found on the product.The site never used sepsiderm to clean the catheter.No ointment(s) were utilized at the exit site.No wound dressing(s) were utilized.It was also stated that laparoscopic surgery was done to resolve the broken catheter in the abdomen.The patient required an x-ray as part of the original procedure for the removal of the catheter.All parts of the catheter were removed, and the procedure was completed.The anesthetic time was not extended by 30 minutes or greater.After the catheter was removed, the patient switched to hemodialysis with other product, and they were able to proceed and complete the treatment.After almost three months when the catheter was implanted, the patient was hospitalized for five days.There was no additional medical intervention required to retrieve the broken portion of the device.No treatment (lotions/ointments, medications) by prescription or over the counter (otc) was used.There was no blood loss, and blood transfusion was not required.The product was replaced.The patient was stable.
Event or Problem Description
According to the reporter, on (b)(6) 2024, the patient's catheter was examined at the hospital, and it was found that the catheter was seriously displaced.The patient was actively requested to change to hemodialysis and arranged for surgical removal of the catheter.The next day, during removal, it was found that the catheter was broken in the abdominal cavity.The catheter was not repaired, and there was a leak.There was no cleaning agent used on the device.There was no luer adapter issue.Flushing was not done prior to use.Nothing unusual was observed on the device prior to use.No other products were utilized with the device.No other defects or damages were found on the product.The site never used sepsiderm to clean the catheter.No ointment(s) were utilized at the exit site.No wound dressing(s) were utilized.It was also stated that laparoscopic surgery was done to resolve the broken catheter in the abdomen.The patient required an x-ray as part of the original procedure for the removal of the catheter.All parts of the catheter were removed, and the procedure was completed.The anesthetic time was not extended by 30 minutes or greater.After the catheter was removed, the patient switched to hemodialysis, and they were able to proceed and complete the treatment.After almost three months when the catheter was implanted, the patient was hospitalized for five days.There was no additional medical intervention required to retrieve the broken portion of the device.No treatment (lotions/ointments, medications) by prescription or over-the-counter (otc) was used.There was no blood loss, and blood transfusion was not required.The product was replaced.The patient was stable.
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: b5, g3 correction: b6 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 examination at the hospital on (b)(6) 2024, there was inadequate drainage, the patient's catheter was examined at the hospital, and it was found that the catheter was seriously displaced.The patient was actively requested to change to hemodialysis and arranged for surgical removal of the catheter.The next day, during removal, on the day of surgery in the pd (peritoneal dialysis) room, it was found that the catheter had a leak, which was a rupture that occurred at approximately two centimeters at the lower end of the internal cuff in the abdominal cavity.The catheter was not repaired.There was no cleaning agent used on the device.There was no luer adapter issue.Flushing was not done prior to use.Nothing unusual was observed on the device prior to use.No other products were utilized with the device.No other defects or damages were found on the product.The site never used sepsiderm to clean the catheter.No ointment(s) were utilized at the exit site.No wound dressing(s) were utilized.It was also stated that laparoscopic surgery was done to resolve the broken catheter in the abdomen.The patient required an x-ray as part of the original procedure for the removal of the catheter.All parts of the catheter were removed, and the procedure was completed.The anesthetic time was not extended by 30 minutes or greater.After the catheter was removed, the patient switched to hemodialysis with other product, and they were able to proceed and complete the treatment.After almost three months when the catheter was implanted, the patient was hospitalized for five days.There was no additional medical intervention required to retrieve the broken portion of the device.No treatment (lotions/ointments, medications) by prescription or over-the-counter (otc) was used.There was no blood loss, and blood transfusion was not required.The product was replaced.The patient was stable.
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 examination at the hospital on (b)(6) 2024, there was inadequate drainage, the patient's catheter was examined at the hospital, and it was found that the catheter was seriously displaced.The patient was actively requested to change to hemodialysis and arranged for surgical removal of the catheter.The next day, during removal, on the day of surgery, it was found that the catheter was broken (ruptured) in the abdominal cavity.The catheter was not repaired, and there was a leak in the catheter at the pd (peritoneal dialysis) room.There was no cleaning agent used on the device.There was no luer adapter issue.Flushing was not done prior to use.Nothing unusual was observed on the device prior to use.No other products were utilized with the device.No other defects or damages were found on the product.The site never used sepsiderm to clean the catheter.No ointment(s) were utilized at the exit site.No wound dressing(s) were utilized.It was also stated that laparoscopic surgery was done to resolve the broken catheter in the abdomen.The patient required an x-ray as part of the original procedure for the removal of the catheter.All parts of the catheter were removed, and the procedure was completed.The anesthetic time was not extended by 30 minutes or greater.After the catheter was removed, the patient switched to hemodialysis with other product, and they were able to proceed and complete the treatment.After almost three months when the catheter was implanted, the patient was hospitalized for five days.There was no additional medical intervention required to retrieve the broken portion of the device.No treatment (lotions/ointments, medications) by prescription or over-the-counter (otc) was used.There was no blood loss, and blood transfusion was not required.The product was replaced.The patient was stable.

• 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: 19571050
• Report Number: 1282497-2024-00176
• Device Sequence Number: 8470375
• Product Code: FJS
• UDI-Device Identifier: 10884521054974
• UDI-Public: 10884521054974
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K180485
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 09/17/2025
• Device Model Number: 8888411405
• Device Catalogue Number: 8888411405
• Device Lot Number: 2026000137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/21/2024; 06/25/2024; 07/10/2024; 07/11/2024; 08/06/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/27/2024; 07/10/2024; 07/10/2024; 07/30/2024; 08/28/2024
• Date Device Manufactured: 11/18/2020
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian