BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1712700 · Received June 2, 2010

    Report

    Report Number
    MW5016205
    Event Type
    Injury
    Date Received
    June 2, 2010
    Date of Event
    May 18, 2010
    Report Date
    June 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HYDRATOME RX44 AFTER BEING PUT DOWN THE SCOPE FOR AN ERCP WAS NOTED TO HAVE A DEFECT AT THE TIP. THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE TOME UP THE BILE DUCT. THE HYDRATOME WAS REMOVED AND SECOND HYDRATOME WAS OPENED AND USED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC HYDRATOME KNS BOSTON SCIENTIFIC MOO583040 13306785

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability