BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1193350 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05132
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO DEVICE DISPOSAL, LOT NUMBER, MANUFACTURER AND EXPIRATION DATE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED IN THE COMPLAINT. PRODUCT ANALYSIS COULD NOT BE PERFORMED, DUE TO THE DEVICE NOT BEING RETURNED, AS THE DEVICE HAS BEEN DISPOSED OF. BASED ON THE EVAL OF OTHER DEVICES THAT HAVE BEEN RETURNED WITH THE SAME ISSUE (CANNULATING ORIENTATION), THE ROOT CAUSE OF THE BROKEN CUTTING WIRE COULD BE DUE TO USER HANDLING, DEVICE DESIGN OR MANUFACTURING/PACKAGING. WITHOUT EVALUATING THE COMPLAINT PRODUCT THE SPECIFIC ROOT CAUSE OF THIS COMPLAINT CAN NOT BE DETERMINED. SO THE ROOT CAUSE IS CLASSIFIED AS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD), THE TOME WAS REPORTEDLY NOT ORIENTING PROPERLY, WHEN IT CAME OUT OF THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THE PT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR