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

Model Number	8888145041P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
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, before the connection of outpatient dialysis in the outpatient dialysis practice, a fracture or crack of the thread on the blue (venous) adapter was seen.It was also stated that it had a broken venous hub.There were no indications of an acute impairment of the patient's condition, air ingress, or leakage.Four days after the initial observation, the patient was presented to them, they repaired the catheter by replacing the venous adapter using the company's acute and chronic catheter repair kit with a different lot.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: a4, b3, b5, g3, h6.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, while the patient was in the outpatient dialysis center, and it was unknown whether it occurred during connection or disconnection, a fracture or crack of the thread on the blue (venous) adapter/connection part was seen.There were no indications of an acute impairment of the patient's condition.No fluid leakage was observed at the defect when the clamp of the leg was closed, and visually, no major air ingress was noted.The adapters were tightened by hand.No other products were being utilized with the device.There was no tego adapter on the catheter when the doctor received the patient.No other defects or damages were found on the product.On the same day after the initial observation, the patient was presented to them, and they repaired the catheter as an intervention by replacing the venous adapter (the attachment/connector piece on the venous snail) using the company's acute and chronic catheter repair kit with a different lot and product id (identifier).The catheter was not removed.It was unlikely that any of the patient's conditions contributed to the rupture of the venous connector.There was no blood loss.No blood transfusion was 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: 22120338
• Report Number: 1282497-2025-00371
• Device Sequence Number: 4251720
• Product Code: MSD
• UDI-Device Identifier: 10884521158047
• UDI-Public: 10884521158047
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 8888145041P
• Device Catalogue Number: 8888145041P
• Device Lot Number: 2427700234
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/31/2025
• Supplement Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 11/07/2024
• 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: 89 YR
• Patient Sex: Unknown
• Patient Weight: 87 KG