BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1070474 · Received July 7, 2008

    Report

    Report Number
    3005099803-2008-01065
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Report Date
    June 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE, RESISTANCE ADVANCING OVER THE GUIDEWIRE OCCURRED. A JAG PRECURSOR ANG B2 GUIDEWIRE HAD BEEN ADVANCED TO AN UNSPECIFIED BILIARY LOCATION. A NON-BSC CUTTING WIRE AND SCOPE HAD BEEN USED SUCCESSFULLY WITH THE GUIDEWIRE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE AN UNSPECIFIED TYPE OF BSC BRUSH OVER THE GUIDEWIRE BUT ENCOUNTERED RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAG PRECURSOR ANG B2 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC M0055661011 11527833

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS| OLYMPUS