BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1022786 · Received March 28, 2008

    Report

    Report Number
    2134265-2008-00910
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.00X15MM APEX MONORAIL BALLOON CATHETER WAS INFLATED ON THE FIRST INFLATION TO NOMINAL PRESSURE AND THEN WAS INFLATED THE SECOND TIME TO 10ATMS AND RUPTURED. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD". THIS PRODUCT IS ONLY OUS APPROVED BUT SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL PTCA DILATATION CATHETER LOX BOSTON SCIENTIFIC 2.00X15MM 11166724

    Patients

    Seq Age Sex Outcome Treatment
    1