BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC/ENCORE/ADVANTAGE

    MDR report key: 1230418 · Received November 7, 2008

    Report

    Report Number
    2134265-2008-04271
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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 FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THERE WERE AIR BUBBLES IN THE INFLATION DEVICE. WHEN THE MODEL-ADVANTAGE 26 INFLATION DEVICE WAS USED TO INFLATE A BALLOON, AIR BUBBLES WERE NOTICED GOING INSIDE THE BALLOON WHICH CAUSED LESS VISIBILITY OF THE BALLOON UNDER X-RAY. THEY NEEDED TO REMOVE THE BUBBLES TO HAVE A BETTER VIEW. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC/ENCORE/ADVANTAGE MAV SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC CORPORATION NA 2045159

    Patients

    Seq Age Sex Outcome Treatment
    1