BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIO DYNAMICS

    MDR report key: 1617169 · Received February 23, 2010

    Report

    Report Number
    MW5014909
    Event Type
    Death
    Date Received
    February 23, 2010
    Date of Event
    October 15, 2009
    Report Date
    November 3, 2009
    Manufacturer
    ANGIO DYNAMICS
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE UNDERGOING LOWER EXTREMITY ANGIOGRAM WITH BALLOON ANGIOPLASTY, THE CATHETER BALLOON RUPTURED IN A FEMORAL ARTERY. THE RETAINED BALLOON WAS RETRIEVED BY OPEN EXPOSURE OF THE ARTERY. LATER THAT DAY SHE REQUIRED EMERGENT FEMORAL ENDARTERECTOMY AND PATCH BYPASS TO TREAT PROFOUND ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO DYNAMICS BALLOON CATHETER - PROFILER TIP LOX ANGIO DYNAMICS UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| R