BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 1150258 · Received September 3, 2008

    Report

    Report Number
    3005099803-2008-04253
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    February 1, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE JAG PRECURSOR GUIDE WIRE TIP DISINTEGRATED. AS THE GUIDE WIRE WAS ADVANCED FOR THE PROCEDURE, THE METAL TIP REPORTEDLY DISINTEGRATED EXPOSING THE METAL GUIDE WIRE. THE PHYSICIAN REMOVED THE WIRE FROM THE PT AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THE PT WAS REPORTED TO BE STABLE POST PROCEDURE WITH NO COMPLICATIONS. IT IS UNK IF A FRAGMENT OF THE DEVICE REMAINED IN THE PT. ADD'L INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE MDM - GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M0055658010 9492332

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other