BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMCATH

    MDR report key: 12308096 · Received August 11, 2021

    Report

    Report Number
    3009211636-2021-00207
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    July 1, 2021
    Report Date
    August 30, 2021
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    KNZ
    UDI-DI
    10884521009929
    PMA / PMN Number
    K840424
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, 2 YEARS AFTER IMPLANTATION, THE CATHETER WAS TOO FLOPPY AND IT WAS VERY DIFFICULT TO REMOVE, THE CUFF WAS STUCK. TO AVOID THE CATHETER BREAKING OFF IN THE PATIENT, A SMALL INCISION WAS MADE AND THE CUFF WAS SLOWLY DISSECTED AWAY FROM THE CHEST WALL. A SLIGHT TEAR CAN BE NOTED ON THE CATHETER AT THE CUFF WHICH WOULD HAVE BROKEN OFF. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, 2 YEARS AFTER IMPLANTATION, THE CATHETER WAS TOO FLOPPY AND IT WAS VERY DIFFICULT TO REMOVE, THE CUFF WAS STUCK. TO AVOID THE CATHETER BREAKING OFF IN THE PATIENT, A SMALL INCISION WAS MADE AND THE CUFF WAS SLOWLY DISSECTED AWAY FROM THE CHEST WALL. NO EXCESSIVE FORCE USED IN TAKING OUT THE CATHETER BUT WITH JUST A MORE COMPLICATED REMOVAL WITH LARGER INCISION USING A STANDARD MINOR TRAY WITH SCALPEL. THEY NORMALLY DO NOT TAKE OUT UNDER FLUOROSCOPY BUT THEY HAD TO WITH THIS PATIENT. CHLORAPREP OR CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. THE CATHETER WAS REMOVED ON THE DAY OF THE EVENT BECAUSE THE PATIENT NO LONGER REQUIRED DIALYSIS THERAPY. A SLIGHT TEAR CAN BE NOTED ON THE CATHETER AT THE CUFF WHICH WOULD HAVE BROKEN OFF. THE CATHETER WAS NOT REPAIRED OR REPLACED. THE PATIENT HAD NO HARM AND WENT HOME RIGHT AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205651 PERMCATH ACCESSORIES, A-V SHUNT KNZ COVIDIEN MFG SOLUTIONS S.A. 8888169001 10884521009929

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention