BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1213734 · Received October 22, 2008

    Report

    Report Number
    2134265-2008-03088
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 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 90% STENOTIC LESION WAS LOCATED IN THE FIRST OBTUSE MARGINAL (OM1) BRANCH OF THE AVERAGE TORTUOUS LEFT CIRCUMFLEX (LXC) ARTERY. THE LESION CHARACTERISTICS ARE UNK. THE 3.0MM X 8MM APEX MONORAIL CATHETER WAS ADVANCED TO THE LESION AND REPORTED TO HAVE RUPTURED UPON THE FIRST INFLATION OF 12 ATM'S FOR 30 SECONDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT INJURY OR COMPLICATIONS WERE REPORTED. THE PT'S CONDITION WAS REPORTED AS "GOOD". THIS DEVICE 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 3.0X8 MM 11252781

    Patients

    Seq Age Sex Outcome Treatment
    1