BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1242913 · Received November 19, 2008

    Report

    Report Number
    3005099803-2008-06572
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) USING THE HYDRATOME RX SPHINCTEROTOME THE CUT WIRE APPEARED BROKEN. HYDROTOME WAS PASSED DOWN SCOPE, ONCE AT PAPILLA ON EXIT FROM THE SCOPE, THE CUT WIRE APPEARED BROKEN. DECIDED TO REMOVE DEVICE FROM THE SCOPE AND EXAMINE, FINDING IT WAS INDEED BROKEN. NO PART DETACHED, THE DEVICE WAS REMOVED IN ONE PIECE. PROCEDURE WAS COMPLETED WITH A DIFFERENT TOME. THE PT IS REPORTED TO BE IN "STABLE" CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583050 11997618

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK