BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS

    MDR report key: 1222743 · Received October 30, 2008

    Report

    Report Number
    1222743
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TAXUS OVER-THE-WIRE STENT WAS NOT EASILY FED OVER 0.014 WIRE. IT WAS VERY HARD TO TAKE OFF THE WIRE ALSO. THE DOCTOR FELT THAT THE WIRE WAS NOT THE ISSUE BECAUSE ANOTHER SAME SIZE TAXUS WENT ON THE WIRE EASILY. THE PATIENT WAS NOT INJURED SINCE THE DEVICE NEVER ACTUALLY MADE IT INSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS STENT, CORONARY NIQ BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION * 11325192

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR