MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145040P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, a fluid leakage was observed at the subcutaneous tunnel (exit site) of a hemodialysis catheter, requiring its removal.No breach was found on the removed catheter.Fortunately, the arteriovenous fistula was just operational, so it was urgently replaced for further care (catheter reimplantation).No patient health incidents.The action was taken in the care setting for patient management.Device change with explantation of the offending device.The catheter was not repaired.There was no luer adapter issue.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.
Event or Problem Description
According to the reporter, a fluid leakage was observed at the subcutaneous tunnel (exit site) of a hemodialysis catheter, requiring the entire catheter to be removed.No breach was found on the removed catheter.Nothing unusual was observed about the device prior to use.The catheter was not repaired.There was no luer adapter issue.Flushing was done, and nothing particular was observed.There was no excessive force applied to the device.Apart from the reported issue, there were no other visible defects or damages on the product at the time of the incident.The catheter was in place for approximately 7 weeks.The dialysis catheter had to be ablated, but fortunately, the patient had an arteriovenous fistula (avf) that had just become operational and was urgently used/pricked to continue dialysis sessions.It was urgently replaced for further care (catheter reimplantation) as a corrective action.No patient health incidents.The action was taken in the care setting for patient management.Device change with explantation of the offending device.The procedure was completed after the corrective action.There was no medical intervention or treatment required as a result of the incident.There was a small amount of blood loss, and there was no blood transfusion required.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.
Event or Problem Description
According to the reporter, a fluid leakage was observed at the subcutaneous tunnel (exit site) of a hemodialysis catheter, requiring the entire catheter to be removed.No breach was found on the removed catheter.Nothing unusual was observed about the device prior to use.The catheter was not repaired.There was no luer adapter issue.Flushing was done, and nothing particular was observed.There was no excessive force applied to the device.Apart from the reported issue, there were no other visible defects or damages on the product at the time of the incident.The catheter was in place for approximately 7 weeks.Fortunately, the arteriovenous fistula was just operational, so it was urgently replaced for further care (catheter reimplantation) as a corrective action.No patient health incidents.The action was taken in the care setting for patient management.Device change with explantation of the offending device.The procedure was completed after the corrective action.There was no medical intervention or treatment required as a result of the incident.There was a small amount of blood loss, and there was no blood transfusion required.There was no reported patient injury.
Additional Manufacturer Narrative
Correction: 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
Additional information: d9, g3, h3, h6 h3 evaluation summary: mozarc medical 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.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all mozarc medical 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: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: jon cornel ; 15 hampshire street; mansfield, MA 02048 ; 8006464633
• MDR Report Key: 23396153
• Report Number: 1282497-2025-00624
• Device Sequence Number: 18636657
• Product Code: MSD
• UDI-Device Identifier: 10884521158030
• UDI-Public: (01)10884521158030(17)280930(10)2329000408
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/23/2026

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: 8888145040P
• Device Catalogue Number: 8888145040P
• Device Lot Number: 2329000408
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 11/17/2025; 10/07/2025; 02/20/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 10/30/2025; 11/18/2025; 11/18/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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