BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1053267 · Received May 28, 2008

    Report

    Report Number
    3005099803-2008-00565
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE, AND THE CAUSE OF THE EVENT IS UNDETERMINED. A REVIEW OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS FOR THIS LOT. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    A HYDRATOME RX SPHINCTEROTOME WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN A FEMALE PT IN 2008. ACCORDING TO THE COMPLAINANT, "...THE CUTWIRE DISLODGED ITSELF FROM THE CATHETER." THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE AND THE PT WAS REPORTED AS "OK" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11608440

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR