BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK

    MDR report key: 2800990 · Received September 19, 2012

    Report

    Report Number
    2800990
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    February 29, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    AS THE SURGEON WAS ADVANCING THE NC TREK OVER A WIRE, THE SHAFT BROKE PRIOR TO ENTERING THE SHEATH IN THE PATIENT. THE BALLOON AND WIRE WERE REMOVED, AND A NEW NC TREK WAS OBTAINED AND UTILIZED WITHOUT ISSUE. IT IS UNKNOWN IF THE SUBSEQUENT INSTRUMENT WAS OF THE SAME OR DIFFERENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT LABORATORIES, INC. * 1062961

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR