BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1723080 · Received June 8, 2010

    Report

    Report Number
    MW5016289
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ERCP, THE BALLOON WOULD NOT INFLATE DURING THE PROCEDURE. ANOTHER BALLOON WAS OBTAINED AND THE PROCEDURE CONTINUED WITH NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC EXTRACTOR HWB BOSTON SCIENTIFIC 4690 13297128

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability