BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX PUSH MONORAIL

    MDR report key: 1080622 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02009
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS DISTAL RIGHT CORONARY ARTERY. ON THE FIRST INFLATION THE 1.5X15MM APEX PUSH MONORAIL BALLOON WAS INFLATED FOR 5 SECONDS AND RUPTURED AT 6 ATMOSPHERES. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT STATUS IS LISTED AS "NO PROBLEM" WITH NO COMPLICATIONS REPORTED. THIS DEVICE IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A 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 11445442

    Patients

    Seq Age Sex Outcome Treatment
    1