BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1191924 · Received October 1, 2008

    Report

    Report Number
    2134265-2008-02843
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON TORTUOUS BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND FIRST DIAGONAL. THE LESION WAS PREDILATED WITH A 2.5X12MM NON BSC DEVICE AND AFTER STENTING OF THE BIFURCATION THE PHYSICIAN DECIDED TO PERFORM A FINAL KISSING BALLOON TECHNIQUE. A 2.5X12MM NON BSC DEVICE WAS INTRODUCED INTO THE LESION AND THEN A 2.5X12MM APEX MONORAIL DEVICE IN A 6F GUIDE NON BSC GUIDE CATHETER WAS INTRODUCED. HOWEVER, WHILE INTRODUCING THE APEX DEVICE, THE SHAFT OF THE DEVICE BROKE. THE APEX BALLOON WAS NOT USED AND WAS EASILY WITHDRAWN BECAUSE IT WAS IN THE BEGINNING OF THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS REPORTED. THE PT'S CURRENT CONDITION IS LISTED AS "STABLE". THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.5X12MM 11572712

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR