BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1052950 · Received May 27, 2008

    Report

    Report Number
    2134265-2008-01500
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.0X15MM APEX MONORAIL BALLOON WAS USED TO PREDILATE THE LESION AND IT WAS NOTED THAT THERE WAS DIFFICULTY CROSSING THE LESION. THE BALLOON RUPTURED ON THE FIRST INFLATION AT 4ATMS. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'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 2.0X15MM 11153069

    Patients

    Seq Age Sex Outcome Treatment
    1