BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1172129 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02695
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS THE DEVICE WAS DISPOSED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH NUMBER FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT, DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE 85% STENONIC, MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE APEX 12MM X 2.5MM BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED 2 TIMES FOR PREDILATION. THE INFLATION TIMES AND PRESSURES WERE UNK. DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE, AND THE TIME WAS UNK. THE BALLOON WAS REMOVED INTACT FROM THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MFR'S DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUES IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.5X12 MM 11100826

    Patients

    Seq Age Sex Outcome Treatment
    1 GOODMAN LACROSS BALLOON CATHETER