BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1061782 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00715
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A HYDRATOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON A FEMALE PT (WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, "THE TIP OF THE SPHINCTEROTOME WAS TORN WHEN IT CAME OUT OF THE DISTAL END OF THE SCOPE." REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH A SECOND HYDRATOME RX SPHINCTEROTOME DEVICE. IT WAS FURTHER REPORTED THAT THERE WERE NO PT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PT'S CONDITION AFTER THE PROCEDURE WAS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME FDI BOSTON SCIENTIFIC CORPORATION M00583060 11578187

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR