BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1200088 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05281
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND CONFIRMED THAT THE DEVICE MET ALL REQUIRED SPECIFICATIONS UPON IT RELEASE. THERE WERE NO OTHER COMPLAINTS RECEIVED ON THIS BATCH NUMBER. BASED ON THE EVALUATION OF OTHER DEVICES WITH THE SAME COMPLAINT OF SPLIT OR CRACKED TIP, THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS TYPE OF PHENOMENA COULD BE DUE TO USER HANDLING, CAUSED BY ANOTHER DEVICE OR MANUFACTURING, BUT CANNOT BE DETERMINED WITH OUT EVALUATING THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) OF THE DUODENUM, PRIOR TO CANNULATION, THE DEVICE CAME OUT OF THE SCOPE WITH A FRAYED TIP. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11942497

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK