BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRETE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 823320 · Received February 2, 2007

    Report

    Report Number
    6000089-2007-00156
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    January 3, 2007
    Report Date
    January 5, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAF
    PMA / PMN Number
    p040016
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE SHAFT OF THE LIBERTE' MONORAIL STENT DELIVERY SYSTEM BROKE. THE LOCATION OF THE LESION IS UNKNOWN BUT, WAS REPORTED TO BE TORTUOUS AND NON CALCIFIED. THE PHYSICIAN EXPERIENCED DIFFICULTY CROSSING THE LESION AND THE SHAFT OF THE DELIVERY DEVICE BROKE. WHILE ATTEMPTING TO RETRACT THE DELIVERY SYSTEM BACK INTO THE GUIDE CATHETER, THE DELIVERY SYSTEM BACAME CAUGHT ON THE GUIDE WIRE AND GUIDE CATHETER. THE DEVICE WAS REMOVED WITH THE GUIDE WIRE AND GUIDE CATHETER AS ONE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBRETE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORP. NA 0009220784

    Patients

    Seq Age Sex Outcome Treatment
    1 *