BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1061942 · Received June 16, 2008

    Report

    Report Number
    2134265-2008-01697
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE 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 AN ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE EXTREMELY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.0 X 15 MM APEX MONORAIL BALLOON WAS USED FOR PREDILATION AND WAS ADVANCED TO THE LESION. UPON THE FIRST INFLATION THE BALLOON BURST AT 10 ATMS AFTER 10 SECONDS. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE". THIS PROD 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 2.0X15MM 11386478

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR