BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1172543 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04644
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STONE REMOVAL PROCEDURE, GUIDE WIRE COATING DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE COMMON BILE DUCT (CBD). THE 0.035 JAG PRECURSOR GUIDE WIRE WAS ADVANCED THROUGH ANOTHER MANUFACTURER'S ENDOSCOPE, HOWEVER, AT AN UNSPECIFIED TIME THE GUIDE WIRE'S DISTAL COATING "WAS LIFTED UP UNDER THE ENDOSCOPE". NONE OF THE COATING REMAINED INSIDE THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC M0055660011 11684460

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS JF260V ENDOSCOPE