BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK 5FR MICROPUNCTURE

    MDR report key: 1081170 · Received July 24, 2008

    Report

    Report Number
    MW5007781
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 27, 2008
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MALE WITH PMH OF HTN, CAD, CABG, PPM. ADMITTED ON 5/28 WITH SOB AND CP, CHF. MYOPATHY EF 20-25%. ON 6/5, TO OR FOR INSERTION OF AIDS. ACCESS WAS OBTAINED USING MICRO PUNCTURE (5F) SMALL GUIDE WIRE WAS ADVANCED. AFTER ADVANCING DILATOR AND PULLING OUT THE GUIDE WHERE IT WAS NOTED THAT THE TINY TIP OF THE WIRE HAD BEEN SHEARED OFF. UNDER FLUORO, FOUND THE SUBCLAVIAN VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK 5FR MICROPUNCTURE INTRODUCER SET DYB MPI S - 501 2059014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other