BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1041264 · Received May 9, 2008

    Report

    Report Number
    2134265-2008-01360
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING FOR A CORONARY ARTERY STENTING TREATMENT PROCEDURE, SHAFT FRACTURE OCCURRED. A 2.5X20MM LIBERTE BARE METAL STENT HAD BEEN SELECTED TO TREAT AN UNKNOWN LESION. WHILE THE DEVICE WAS BEING UNPACKED FROM ITS PROTECTIVE COIL, THE "FLEXIBLE" PORTION OF THE STENT DELIVERY SYSTEM DETACHED FROM THE HYPOTUBE. THE DEVICE WAS NOT USED IN THE PROCEDURE AND DID NOT CONTACT THE PT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. 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 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 11406104

    Patients

    Seq Age Sex Outcome Treatment
    1 CORDIS STENT