MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145058P
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during insertion on the patient, when attempting to place the guide wire threads, the guide wire would not advance inside the portion of the catheter and it was stuck.It was necessary to remove the guide wire together (at the same time) with the catheter and when it was removed, it was bent.The guide wire was not frayed, unraveled, or coiled.It was not noticed in the packaging or during visual inspection.The guidewire provided with the kit was being used.No tools used when trying to remove the guidewire.No excessive force required to remove the guidewire.There was a minimal (less than 5mls) blood loss and blood transfusion was not required.No other products being utilized with the device.Nothing unusual observed on the device prior to use.No flushing done prior to use.There was no tego utilized and no luer adapter issue.The insertion site was treated iodine with prior to product placement.The catheter was not repaired and there was no leak.A new kit of the same lot was required and used.The patient had reinsertion with another catheter as intervention.The procedure was completed.There was no reported patient outcome.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 10969038
• Report Number: 3009211636-2020-00302
• Device Sequence Number: 2127861
• Product Code: MSD
• UDI-Device Identifier: 10884521158283
• UDI-Public: 10884521158283
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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 Expiration Date: 09/30/2024
• Device Model Number: 8888145058P
• Device Catalogue Number: 8888145058P
• Device Lot Number: 1929500074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1