BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1061787 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00714
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVAL HAS NOT BEEN PERFORMED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINT, THE WIRE WOULD NOT ADVANCE OUT OF THE SPHINCTEROTOME. AND, WHEN THE WIRE WAS REMOVED FROM THE SPHINCTEROTOME, THE PHYSICIAN AND THE NURSE NOTED THAT THE WIRE WAS "FRAYED." IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A SECOND HYDRATOME RX SPHINCTEROTOME DEVICE. ACCORDING TO THE COMPLAINANT, THERE WERE NO PT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PT'S CONDITION AFTER THE PROCEDURE WAS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME FDI BOSTON SCIENTIFIC CORPORATION M00583040 11607053

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR