BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 2153396 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02012
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (MISORIENTATION). THE DEVICE WAS DISCARDED BY THE USER FACILITY. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. (B)(4).

    Description of Event or Problem · 1

    A HYDRATOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN A MALE PT ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS INCORRECTLY ORIENTATED UPON EXITING THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH A SECOND HYDRATOME RX SPHINCTEROTOME. NO PT COMPLICATIONS WERE 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 M00583000 11264492

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR