BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1691068 · Received May 11, 2010

    Report

    Report Number
    MW5015934
    Event Type
    Injury
    Date Received
    May 11, 2010
    Date of Event
    April 30, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PRE TEST, THE EXTRACTOR BALLOON FAILED TO INFLATE TO 9MM. THE CONNECTIONS WERE CHECKED AND INFLATION WAS AGAIN ATTEMPTED BUT FAILED. A THIRD INFLATION WAS ATTEMPTED TO 12MM AND THAT ATTEMPT ALSO FAILED. A SECOND DEVICE WAS USED WITHOUT ANY FURTHER DIFFICULTIES. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC EXTRACTOR BALLOON FGE BOSTON SCIENTIFIC 4690 13262819

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability