BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURBOHAWK

    MDR report key: 1613700 · Received February 18, 2010

    Report

    Report Number
    MW5014856
    Event Type
    Other
    Date Received
    February 18, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 22, 2009
    Manufacturer
    EV3, INC.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVING THE TURBOHAWK FOR CLEANING, THE DEVICE GOT CAUGHT IN PINNACLE SHEATH CAUSING THE TIP OF THE TURBOHAWK TO COME APART. EVERYTHING RETRIEVED. NO PT INJURY. THERAPY DATES: (B) (6) 2009. DIAGNOSIS FOR USE: PVD. PLEASE RETURN TO CATH LAB FOR REP TO PICK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK LX-C MCW EV3, INC. TH8-LX-C 7884172

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other