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

Model Number	8888145015P
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
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.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) 2024, the patient underwent arteriovenous fistula creation for hemodialysis in the department, followed by regular hemodialysis sessions since then.On (b)(6) 2025, during a dialysis session, bleeding was observed at the connection site of the dialysis circuit and the long-term internal jugular vein catheter.Examination revealed a crack at the catheter connection interface.Investigation suggested that the mismatch in material compatibility between the long-term catheter and the hemodialysis circuit components led to the damage of the catheter junction, meaning the disposable dialysis tubing did not match with the interface of the catheter for hemodialysis.A tego was not utilized.The insertion site was not treated with anything prior to product placement.No other products were being utilized with the device.Nothing unusual was observed on the device prior to use.No other defects or damages were found on the product.The long-term internal jugular vein catheter was repaired by replacing the interface, and an arteriovenous fistula for hemodialysis was reconstructed as intervention.The new catheter connector was installed, and no further bleeding was observed.Renal dialysis was performed.After the repair, dialysis treatment was completed.The patient did not have an infection due to the event.The amount of blood lost (ml) as a result of the event was unspecified.Blood transfusion was not required.There was no reported patient injury.

• 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: 22307377
• Report Number: 1282497-2025-00430
• Device Sequence Number: 18297935
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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
• 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: 06/23/2025
• 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: 81 YR
• Patient Sex: Unknown