BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1032615 · Received April 22, 2008

    Report

    Report Number
    2134265-2008-01161
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE 5.0 X 16 MM LIBERTE' STENT WAS SUCCESSFULLY PLACED. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DELIVERY DEVICE, WHICH BECAME LODGED INSIDE THE GUIDE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    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 11139792

    Patients

    Seq Age Sex Outcome Treatment
    1