BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1140589 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04188
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THE REPORTED COMPLAINT. THE TOME DEVICE AND THE HYDRAJAG GUIDEWIRE WERE NOT RETURNED FOR PRODUCT ANALYSIS AS THE CUSTOMER HAS DISPOSED THE DEVICE; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) , USING A HYDRATOME RX 44 SPHINCTEROTOME, THE PHYSICIAN NOTICED THE WIRE WAS BROKEN. THE PHYSICIAN CANNULATED THE COMMON BILE DUCT (CBD) WITH THE HYDRATOME. BEFORE PERFORMING A SPHINCTEROTOMY, THE PHYSICIAN NOTICED THAT THE PRELOADED HYDRAWIRE IN THE HYDRATOME WAS BROKEN IN THE MIDDLE OF THE WIRE. THE HYDRATOME AND BROKEN HYDRAWIRE WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT HYDRATOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 0011794783

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BSC - HYDRA JAGWIRE-GUIDEWIRE