BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1638244 · Received March 18, 2010

    Report

    Report Number
    MW5015233
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    March 13, 2010
    Report Date
    March 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PATIENT WAS UNDERGOING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, AS THE PRACTITIONER WAS OBTAINING A PAPILLOTOMY, THE CUTTING WIRE BROKE, SO NO FURTHER CURRENT COULD BE OBTAINED. THIS ULTRATOME WAS WITHDRAWN WITH INCIDENT AND A NEW ULTRATOME WAS INSERTED AND THE PROCEDURE COMPLETED. PATIENT EXPERIENCED NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC ULTRATOME 5MM SHORT NOSE KNS BOSTON SCIENTIFIC M00530800 12687637

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other