BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 1071323 · Received July 8, 2008

    Report

    Report Number
    3005099803-2008-01083
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ERCP PROCEDURE, THE TIP OF THE GUIDEWIRE TIP DETACHED. A JAG PRECURSOR ST HAD BEEN SELECTED AND ADVANCED TO THE BILE DUCT. AN "ULTRATOM" DEVICE HAD BEEN USED AT AN UNSPECIFIED TIME DURING THE PROCEDURE WITH THE GUIDEWIRE. ABOUT 20 MINUTES INTO THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE IN MOVING THE GUIDEWIRE WITHIN THE SCOPE AND THE TIP OF THE GUIDEWIRE DISLODGED INSIDE THE PT. THE PHYSICIAN WAS ABLE TO "MOVE" THE DISLODGED TIP TO AN UNSPECIFIED LOCATION WITHIN THE PATIENT'S INTESTINAL TRACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE KNY BOSTON SCIENTIFIC M0055658010

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other OLYMPUS METAL SCOPE