BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1191146 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04895
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVAL WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS INFORMED BY THE PHYSICIAN, USING A HYDRATOME RX SPHINCTEROTOME IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), THAT THE ORIENTATION WAS BAD, AND THE TOME WOULD BARELY BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, THE PT IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583000 0011924106

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR