BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1082649 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01240
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 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 UNSPECIFIED ENDOSCOPIC PROCEDURE THE GUIDEWIRE FAILED TO ADVANCE. A JAG PRECURSOR 035/450 ANG GUIDEWIRE HAD BEEN SELECTED FOR USE IN AN UNSPECIFIED ENDOSCOPIC PROCEDURE. DURING INSERTION INTO A NON-BSC CANNULA, RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS EXCHANGED FOR A NON-BSC WIRE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC M0055659011 11563951

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS REVOWAVE WIRE| OLYMPUS REUSE