BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1061937 · Received June 16, 2008

    Report

    Report Number
    2134265-2008-01683
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING OF A 3.50X24MM LIBERTE BARE METAL STENT, IT WAS OBSERVED THAT THE INNER PACKAGING OF THE STENT WAS NOT PROPERLY CLOSED AND THEREFORE, THE DEVICE WAS NOT STERILE. THE DEVICE WAS NOT USED. THE PROCEDURE WAS FINISHED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 0011596606

    Patients

    Seq Age Sex Outcome Treatment
    1