BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1213669 · Received October 23, 2008

    Report

    Report Number
    2134265-2008-03069
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON. THE PHYSICIAN WAS PREPPING TO USE A LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM 3.50 X 24 MM IN UNK LESION, THE STENT SLID BACKWARDS OFF THE BALLOON UNTO THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO COMPLICATIONS OCCURRED.

    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 11559178

    Patients

    Seq Age Sex Outcome Treatment
    1