BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1082530 · Received July 22, 2008

    Report

    Report Number
    3005099803-2008-01228
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVAL, IT HAS NOT BEEN RECEIVED. THE DEVICE EVAL HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS THE FIRST OF TWO REPORTED MALFUNCTIONS OCCURRING DURING THE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ONE DAY PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE ERCP, THE CUTTING WIRE OF THE SPHINCTEROTOME BROKE. THE DEVICE WAS REPLACED BY AN AUTOTOME RX SPHINCTEROTOME DEVICE. REFER TO MFR REPORT # 3005099803-2008-01229 FOR DETAILS REGARDING THIS SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11665052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK