BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1172128 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02684
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    AS NO DEVICE WAS RECEIVED FOR ANALYSIS IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESSES ALL UNITS ARE 100% VISUALLY INSPECTED FOR ANY POSSIBLE DAMAGES AND ARE PACKAGED APPROPRIATELY IN ORDER TO PROTECT THE DEVICE FROM EXTERNAL DAMAGE DURING SHIPMENT. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, A BALLOON BURST OCCURRED. THE 99% STENOSED, CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO INFLATE THE LESION USING AN APEX MONORAIL 2.5X12MM AND AFTER THE FIRST INFLATION AT 15ATM, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A NON BSC PRODUCT. PATIENT STATUS AFTER PROCEDURE IS "NO PROBLEM". 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 CORPORATION 2.5X12 MM 0011103481

    Patients

    Seq Age Sex Outcome Treatment
    1 SPRINTER LEGEND BALLOON