BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1140594 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04144
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WHEN THE SPHINCTEROTOME ENTERED OUT OF THE SCOPE, THE ORIENTATION WAS INCORRECT. THE PRODUCT WAS REMOVED FROM THE SCOPE AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO TWIST THE TIP OF THE SPHINCTEROTOME BACK TO THE ORIGINAL ORIENTATION. THE SPHINCTEROTOME WAS REPLACED WITH A DIFFERENT SPHINCTEROTOME AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583020 11831684

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK