BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST CATH

    MDR report key: 3253798 · Received July 25, 2013

    Report

    Report Number
    3253798
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 25, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD WAS REMOVING THE SHEATH FROM THE FEMORAL VEIN AND IT BROKE, LEAVING PART OF THE SHEATH IN THE PATIENT'S VEIN. MD HAD TO USE SURGICAL INSTRUMENTS TO REACH INTO THE VEIN TO REMOVE THE REST OF THE SHEATH.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?STENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349034 FAST CATH INTRODUCER, CATHETER DYB ST. JUDE MEDICAL * 4035604
    349035 * ---

    Patients

    Seq Age Sex Outcome Treatment
    1 *