BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX FLEX MONORAIL

    MDR report key: 1181527 · Received September 25, 2008

    Report

    Report Number
    2134265-2008-02810
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 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

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE THE PERFORMANCE OF THE DEVICE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE EXTREMELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX. A 1.5X8 MM APEX FLEX MONORAIL BALLOON WAS USED SEVERAL TIMES AND RUPTURED AT 8 ATMOSPHERES. IT IS UNK EXACTLY HOW MANY INFLATIONS WERE PERFORMED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PT STATUS IS GOOD WITH NO COMPLICATIONS REPORTED. 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 FLEX MONORAIL NA LOX BOSTON SCIENTIFIC 1.5X8 MM 11433531

    Patients

    Seq Age Sex Outcome Treatment
    1