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

Model Number	8888411405
Medical Device Problem Codes	Break (1069); Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, on (b)(6) 2025, the gauze covering the outlet of the catheter was found to be wet at home.Upon returning to the hospital for examination, the catheter was found to be damaged with a crack, which led to leakage.It was also noted that the area near the catheter exit appeared opaque and milky white.The patient was immediately scheduled for hospitalization, and peritoneal dialysis (pd) was suspended.During the replantation, the patient was hospitalized for four days, from (b)(6) 2025, to (b)(6) 2025.There was no issue with the luer adapter, and nothing unusual was observed on the device prior to use.Flushing was done prior to use with normal results.No other products were being utilized with the catheter, and no excessive force was used.Nonalcoholic povidone-iodine and normal saline were used for disinfection, while sterile gauze was used as the wound dressing.The wound dressing contained gentamicin 0.1% cream, which has cleaning agent or antimicrobial properties.The cleaning agents were allowed to dry thoroughly before the dressing was applied and before ointments were used on the area.The patient was responsible for catheter maintenance.On february 19, as a remedial action, the catheter was removed, a new catheter was inserted, and the treatment was completed.The hospital applied gentamicin cream once a day for a prolonged period, in accordance with the ispd (international society for peritoneal dialysis) care guidelines.Currently, the patient is doing well with no signs of peritonitis.
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 (b)(6) 2025, it was noticed that the gauze covering the outlet of the catheter was wet at home.When the patient returned to the hospital for an examination, it was found that the catheter was damaged with a crack, which led to leakage.The area near the catheter exit also appeared opaque and milky white.As a result, the patient was immediately scheduled for hospitalization, and peritoneal dialysis (pd) was suspended.During replantation, the patient was hospitalized for four days, from (b)(6) 2025.There were no issues with the luer adapter, and nothing unusual was observed with the device prior to use.The catheter was flushed prior to use with normal results.No other products were utilized with the catheter, and no excessive force was applied.Non-alcoholic povidone-iodine and normal saline were used for disinfection, and sterile gauze was used as the wound dressing.The dressing contained gentamicin 0.1% cream, which has antimicrobial properties.The cleaning agents were allowed to dry thoroughly before the dressing was applied and before ointments were used on the area.The patient was responsible for catheter maintenance and applied gentamicin ointment to the skin around the catheter outlet (which would touch the catheter near the ski n) as both a cleaning agent and antibiotic.The cleaning agents were never mixed, and sepsiderm was never used to clean the catheter.At the beginning, the patient received iodide and normal saline as cleaning agents, but after one month, only normal saline was used.On (b)(6), as a remedial action, the damaged catheter was removed, and a new catheter was inserted.The treatment was completed.In accordance with ispd (b)(6) care guidelines, the hospital applied gentamicin cream once daily for an extended period.At the time of reporting, the patient was doing well and showed no signs of peritonitis.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, on (b)(6) 2025, it was noticed that the gauze covering the outlet of the catheter was wet at home.When the patient returned to the hospital for an examination, it was found that the catheter was damaged with a crack, which led to leakage.The area near the catheter exit also appeared opaque and milky white.As a result, the patient was immediately scheduled for hospitalization, and peritoneal dialysis (pd) was suspended.During replantation, the patient was hospitalized for four days, from (b)(6) 2025.There were no issues with the luer adapter, and nothing unusual was observed with the device prior to use.The catheter was flushed prior to use with normal results.No other products were utilized with the catheter, and no excessive force was applied.Non-alcoholic povidone-iodine and normal saline were used for disinfection, and sterile gauze was used as the wound dressing.The dressing contained gentamicin 0.1% cream, which has antimicrobial properties.The cleaning agents were allowed to dry thoroughly before the dressing was applied and before ointments were used on the area.The patient was responsible for catheter maintenance and applied gentamicin ointment to the skin around the catheter outlet (which would touch the catheter near the skin) as both a cleaning agent and antibiotic.The cleaning agents were never mixed, and sepsiderm was never used to clean the catheter.At the beginning, the patient received iodide and normal saline as cleaning agents, but after one month, only normal saline was used.There was no protocol change for cleaning agents.On (b)(6) as a remedial action, the damaged catheter was removed, and a new catheter was inserted.The treatment was completed.In accordance with ispd (international society for peritoneal dialysis) care guidelines, the hospital applied gentamicin cream once daily for an extended period.Currently, the patient is doing well and shows no signs of peritonitis.
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.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted one catheter, with a pin-hole leak.Along with this, there also appeared to be yellow discoloration to the catheter's cannula.It was reported that there was a crack and leak on the catheter shaft.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.It was also reported that the device was discolored.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.
Additional Manufacturer Narrative
Additional information: d9, 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 one catheter, with visible signs of use and a pin-hole leak.Along with this, there also appeared to be milky-white discoloration to the catheter's cannula.It was reported that there was a hole 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 when the catheter came into contact with a sharp instrument during use.It was also reported that the device was discolored.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.

• 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: 21596581
• Report Number: 1282497-2025-00141
• Device Sequence Number: 8265732
• 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: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/22/2025

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: 8888411405
• Device Catalogue Number: 8888411405
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 03/20/2025; 03/31/2025; 04/10/2025; 08/21/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/24/2025; 04/02/2025; 04/15/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown