BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME XL SPHINCTEROTOME

    MDR report key: 1081994 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01253
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN ULTRA XL SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED THAT THE SPHINCTEROTOME CUTTING WIRE WAS BROKEN JUST PRIOR TO INITIATING THE SPHINCTEROTOMY. THE DEVICE WAS REPLACED WITH A SECOND ULTRATOME XL SPHINCTEROTOME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATOME XL SPHINCTEROTOME FDI BOSTON SCIENTIFIC CORPORATION M00535920 11337723

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK