BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1161492 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04583
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    July 27, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE CODES WERE SELECTED BY THE MFR BASED ON INFO OBTAINED FROM THE USER FACILITY. 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 CORP IN 2008, THAT A HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON THE EVENT DATE. ACCORDING TO THE COMPLAINANT, WHILE TRYING TO INJECT CONTRAST, IT WAS NOTED TO BE LEAKING FROM THE SHAFT OF THE HYDRATOME DEVICE (APPROX 4 CM FROM THE TIP); NO CONTRAST CAME OUT OF THE TIP. ANOTHER HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583050 11574355

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR