BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1031455 · Received April 18, 2008

    Report

    Report Number
    2134265-2008-01138
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 31, 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

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 THER IS ANY FURTHER RELEVANT INFO 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 BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED MID LEFT CIRCUMFLEX (LCX). THE LESION WAS PREDILATED WITH A 1.5MM APEX BALLOON. A 2.00X8MM APEX BALLOON WAS THEN DILATED IN THE LESION AND DURING THE SECOND INFLATION THE APEX BALLOON RUPTURED AT 12 ATMS. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PT AND THE PROCEDURE WAS COMPLETED WITH A 2.5MM NON BSC DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD". 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 2.00X8MM 11223992

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR