BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX SPHINCTEROTOME

    MDR report key: 1133474 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03832
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVAL; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED, THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A JAGTOME RX SPHINCTEROTOME DEVICE WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE USER WAS UNABLE TO LOAD THE GUIDEWIRE INTO THE CANNULA. "WHEN THE GUIDEWIRE WAS 3/4 OF THE WAY DOWN THE CANNULA, THE GUIDEWIRE WOULD POP OUT OF THE SIDE OF THE CANNULA." THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX SPHINCTEROTOME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00573040 11823564

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK