BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2213788 · Received April 21, 2008

    Report

    Report Number
    MW5021736
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    BALLOON RUPTURED INSIDE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC BALLOON LOX BOSTON SCIENTIFIC 510 BALLOON 7571712

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR