BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 891300 · Received August 3, 2007

    Report

    Report Number
    891300
    Event Type
    Death
    Date Received
    August 3, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 30, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ATTEMPTED STENT OF VEIN GRAFT, VESSEL WAS RE-DILATED WITH A 3.5MM BALLOON. FOLLOWING BALLOON INFLATION, THE PT COMPLAINED OF BACK PAIN & RIGHT ARM DISCOMFORT. REPEAT ANGIOGRAPH SHOWED DISTAL PERFORATION OF THE VEINGRAFT IN THE VICINITY OF THE TIP OF THE FILTER WIRE DISTAL TO THE SITE OF BALLOON DILATION. IT IS BELIEVED THAT THE BALLOON "WATERMELON SEALED" DISTALLY DURING INFLATION. THEREBY PUSHING THE FILTER DISTALLY. THE PT DEVELOPED CARDIAC TAMPONADE DESPITE USE OF A COVERED STENT AND PERIOCARDIAC TESTS. PT EXPIRED BEFORE SURGICAL DRAINAGE COULD BE PERFORMED. SEE # 5 & 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC FILTERWIRE EZ NFA BOSTON SCIENTIFIC 20100-300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death QUANTUM 3.5 X 30