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

Model Number	8888145015P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the patient underwent long-term internal jugular vein catheterization for hemodialysis using a chronic catheter on (b)(6) 2024, followed by regular hemodialysis sessions.On the day of the event, bleeding was observed at the connection point between the long-term catheter and the dialysis circuit during a session.Examination revealed a crack at the interface venous (blue).Investigation suggested that the mismatch in material compatibility between the long-term catheter and the dialysis circuit components caused the connector to rupture.There was a crack and a leak.Tego was not utilized.Nothing unusual was observed on the device prior to use.Flushing was done with normal results.No excessive forced use on the device.The insertion site was not treated prior to product placement.The cleaning agent(s) are allowed to dry thoroughly prior to applying ointment(s) to the area.The connector was promptly replaced, and no further bleeding was observed.Additionally, an arteriovenous fistula was created to neurovascular access for ongoing dialysis.As a remedial action, the catheter was repaired.The procedure was continued and completed after the remedial action was performed.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.No blood loss, and blood transfusion was not required.The intervention/treatment was replacing the catheter connector.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.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22257025
• Report Number: 1282497-2025-00416
• Device Sequence Number: 7900436
• Product Code: MSD
• UDI-Device Identifier: 10884521157989
• UDI-Public: 10884521157989
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 06/17/2025

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: 8888145015P
• Device Catalogue Number: 8888145015P
• Device Lot Number: 2329000418
• 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: 06/12/2025
• Initial Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 10/29/2023
• 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 Age: 73 YR
• Patient Sex: Unknown