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

Model Number	8888411405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
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, a week after the cuff was removed, leakage was found at the cuff removal site.Flushing was done prior to use, and the catheter test 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 where the leak observed.No ointment(s) were utilized at the exit site.The wound dressing did not include any cleaning agents or antimicrobial properties.The patient was responsible for any type of catheter maintenance, and it was cleaned with saline solution.The site never used sepsiderm to clean catheters.The catheter had been in placed for 29 days.The patient was reluctant to continue pd (peritoneal dialysis) therapy because of the catheter problem, so the pd (peritoneal dialysis) catheter was removed, and they changed to hd (hemodialysis) therapy, which solved the issue.There was no blood loss.A blood transfusion was not required.The catheter problem was addressed by surgical management.There was no reported pati ent 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.
Event or Problem Description
According to the reporter, a week after the cuff was removed, leakage was found at the cuff removal site at the exit site of the catheter from the pd (peritoneal dialysis) tube shaft.Flushing was done prior to use, and the catheter test 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 where the leak observed.No ointment(s) were utilized at the exit site.They were covered with sterile gauze which was a routine procedure.The wound dressing did not include any cleaning agents or antimicrobial properties.The patient was not responsible for any type of catheter maintenance; the patient only had the catheter outlet cleaned, and it was cleaned with saline solution.The site never used sepsiderm to clean catheters.The catheter had been in placed for 29 days.The patient was reluctant to continue pd therapy because of the catheter problem, so the pd catheter was removed, and they changed to hd (hemodialysis) therapy, which solved the issue.After changing the treatment mode, this treatment method had been used for continuous treatment.There was no blood loss.A blood transfusion was not required.No medication treatment for the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b3, 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.
Event or Problem Description
According to the reporter, a week after the cuff was removed, leakage was found at the cuff removal site at the exit site of the catheter from the pd (peritoneal dialysis) tube shaft.Flushing was done prior to use, and the catheter test 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 where the leak observed.No ointment(s) were utilized at the exit site.They were covered with sterile gauze.The wound dressing did not include any cleaning agents or antimicrobial properties.The patient was not responsible for any type of catheter maintenance; the patient only had the catheter outlet cleaned, and it was cleaned with saline solution.The site never used sepsiderm to clean catheters.The catheter had been in placed for 29 days.The patient was reluctant to continue pd therapy because of the catheter problem, so the pd catheter was removed, and they changed to hd (hemodialysis) therapy, which solved the issue.There was no blood loss.A blood transfusion was not required.No medication treatment.There was no reported patient injury.
Event or Problem Description
According to the reporter, a week after the cuff was removed, leakage was found at the cuff removal site at the exit site of the catheter from the pd (peritoneal dialysis) tube shaft.Flushing was done prior to use, and the catheter test 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 where the leak observed.No ointment(s) were utilized at the exit site.They were covered with sterile gauze which was a routine procedure.The wound dressing did not include any cleaning agents or antimicrobial properties.The patient was not responsible for any type of catheter maintenance; the patient only had the catheter outlet cleaned, and it was cleaned with saline solution.The site never used sepsiderm to clean catheters.The catheter had been in placed for 29 days.The patient was reluctant to continue pd therapy because of the catheter problem, so the pd catheter was removed, and they changed to hd (hemodialysis) therapy, which solved the issue.After changing the treatment mode, this treatment method had been used for continuous treatment.The treatment was able to be completed.There was no blood loss.A blood transfusion was not required.No medication treatment for the event.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.

• 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: 19930932
• Report Number: 1282497-2024-00302
• Device Sequence Number: 16828239
• 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
• Report Date (Section B): 09/10/2024

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 Expiration Date: 09/17/2025
• Device Model Number: 8888411405
• Device Catalogue Number: 8888411405
• Device Lot Number: 2019500204
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 08/21/2024; 08/29/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/22/2024; 08/30/2024; 09/10/2024
• Date Device Manufactured: 10/21/2020
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian