BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1943531 · Received December 10, 2010

    Report

    Report Number
    1943531
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 26, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CORDIS
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON USED THE OUTBACK RE-ENTRY CATHETER TO RE-ENTER INTO THE PATIENT'S RIGHT SUPERFICIAL FEMORAL ARTERY. IN THE PROCESS ONE OF THE PROWATER WIRES FRACTURED OFF AND WAS THEN DETERMINED TO BE EXTRALUMINAL. SEVERAL ATTEMPTS WERE USED TO MOVE THE CATHETER TIP. ON EXAMINATION BY THE SURGEON OF THE OUTBACK RE-ENTRY CATHETER IT WAS NOTED TO BE UNCOILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CATHETER, PERCUTANEOUS DQY CORDIS OTB-42120 15013024
    2 ASAHI PROWATER WIRE WIRE, GUIDE, CATHETER DQX ABBOTT 14935-02 090722A481

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR