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

Model Number	8888145014P
Medical Device Problem Codes	Break (1069); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, it was reported by the interventional radiology department that a valve on the catheter kit did not work correctly.A customer disposition request was submitted for replacement.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.
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, during insertion into the patient, it was reported by the interventional radiology department that a valve on the catheter kit did not work correctly.The valve issue occurred within the peel-away sheath that was included in the 19 cm (centimeters) dual lumen permanent tunneled dialysis catheter kit.When the doctor went to insert the catheter through the peel-away, the amount of blood coming out was abnormal.After the catheter was successfully placed and the peel-away was removed from the patient, the doctor observed that the peel-away did not have the valve inside of it as it usually would.No malfunction was observed in the clamp, catheter shaft, or bifurcate.There was no issue with the luer adapter.Nothing unusual was observed on the device prior to use.Anesthesia time was not extended by greater than 30 minutes.The patient was treated under local anesthesia.The wound dressing utilized was a competitor¿s gauze.Flushing was done prior to use and the result was normal.No other products were being utilized with the device.No cleaning agent was used on the device.Tego was not utilized.As the device was newly implanted, the insertion site was treated prior to product placement.No other defects/damages found on the product.The procedure was completed successfully.A customer disposition request was submitted for replacement.According to the doctor¿s report, less than 10 ml (milliliters) of blood was lost, no blood transfusion was required, and no medical intervention or treatment was necessary as a result of the event.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: jon cornell ; 15 hampshire street; mansfield, MA 02048 ; 8006464633
• MDR Report Key: 23378395
• Report Number: 1282497-2025-00622
• Device Sequence Number: 8824396
• Product Code: MSD
• UDI-Device Identifier: 10884521157972
• UDI-Public: (01)10884521157972(17)290430(10)241480254(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: 8888145014P
• Device Catalogue Number: 8888145014P
• Device Lot Number: 241480254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 10/27/2025
• Date Device Manufactured: 05/27/2024
• 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: 85 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White