BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX PUSH MONORAIL

    MDR report key: 1083392 · Received July 28, 2008

    Report

    Report Number
    2134265-2008-02111
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 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

    DEVICE EVALUATION: THE DEVICE WAS DISPOSED OF BY THE HOSPITAL; THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND/OR PROCEDURE FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOTIC LESION WAS LOCATED IN THE AVERAGE TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 1.5X15MM APEX PUSH BALLOON CATHETER TO THE LESION AND ATTEMPTED TO INFLATE IT, BUT IT RUPTURED AS SOON AS THE INFLATION WAS STARTED. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. PATIENT STATUS IS REPORTED AS "GOOD". THIS DEVICE IS ONLY OUS APPROVED BUT IS SIMILAR TO MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX PUSH MONORAIL NA LOX BOSTON SCIENTIFIC 1.5X15 MM 11423422

    Patients

    Seq Age Sex Outcome Treatment
    1