BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 4000 CONTROLLER

    MDR report key: 17698786 · Received September 7, 2023

    Report

    Report Number
    2124215-2023-48519
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 17, 2023
    Report Date
    February 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    UDI-DI
    08714729861942
    PMA / PMN Number
    P920047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: P920047, P980003, P020025. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "THE DEVICE IS NOT POWERING UP TO THE DESIRED TEMPERATURE". THE COMPLAINT DEVICE WAS RETURNED AND ANALYZED BY THE SFMD. THE RETURNED DEVICE ANALYSIS SHOWED NO EVIDENCE OF DEFECT, MALFUNCTION OR DAMAGE, THE REPORTED EVENT WAS NOT CONFIRMED. THEREFORE, THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE CONCLUSION CODE OF "NO PROBLEM DETECTED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MAESTRO 4000 CONTROLLER PRESENTED AN ISSUE. THE DEVICE IS NOT POWERING UP TO THE DESIRED TEMPERATURE. NO PATIENT INVOLVEMENT WAS REPORTED. THE WAS NO INDICATION IF THE DEVICE WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MAESTRO 4000 CONTROLLER PRESENTED AN ISSUE. THE DEVICE IS NOT POWERING UP TO THE DESIRED TEMPERATURE. NO PATIENT WAS INVOLVED IN THE EVENT. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC POST MARKET LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090005 MAESTRO 4000 CONTROLLER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC CORPORATION 86338 1114191357 08714729861942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown