BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2170642 · Received July 18, 2011

    Report

    Report Number
    MW5021373
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    May 10, 2011
    Report Date
    July 5, 2011
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON RUPTURED DURING POST DILATION OF STENT. ANGIOPLASTY BALLOON COULD NOT BE RETRIEVED PERCUTANEOUSLY. JUGULAR CUTDOWN REQUIRED FOR REMOVAL OF BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC ANGIOPLASTY BALLOON LOX 14-515

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention