BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 4000 CONTROLLER

    MDR report key: 18065417 · Received November 3, 2023

    Report

    Report Number
    2124215-2023-59798
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 1, 2023
    Report Date
    November 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LPB
    UDI-DI
    08714729861911
    PMA / PMN Number
    P920047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PREMARKET / 510(K) # P980003, P020025 THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. THE GENERATOR TEMPERATURE COULD NOT INCREASE ABOVE 28 DEGREES CELSIUS AND THE ERROR MESSAGE M02 POWER LIMITED, POWER SETTING WAS DISPLAYED. THE GENERATOR POWER COULD NOT BE INCREASED ABOVE 50W. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154355 MAESTRO 4000 CONTROLLER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER LPB BOSTON SCIENTIFIC CORPORATION 86248 0127211743 08714729861911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown