BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 4000 CONTROLLER

    MDR report key: 17852113 · Received October 2, 2023

    Report

    Report Number
    2124215-2023-51333
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 11, 2023
    Report Date
    February 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LPB
    UDI-DI
    08714729861911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) # P920047, P980003, P020025 THE RETURNED MAESTRO 4000 SYSTEM WAS ANALYZED BY AN EXTERNAL PARTY AND THE SYSTEM PASSED ALL TESTS PERFORMED AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED TEMPERATURE ISSUES WERE UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MAESTRO 4000 CONTROLLER PRESENTED AN ISSUE WITH TEMPERATURE CONTROL DURING PROCEDURE, THIS REMAINED AT 27 DEGREES, COOLED AND UNCOOLED DURING ABLATION AND DOES NOT INCREASE. NO PATIENT COMPLICATIONS WERE REPORTED, AND NO ERROR MESSAGES OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MAESTRO 4000 CONTROLLER PRESENTED AN ISSUE WITH TEMPERATURE CONTROL, THIS REMAINED AT 27 C COOLED AND UNCOOLED ABLATION AND DID NOT INCREASE. THE PHYSICIAN AND NURSE OBSERVED THE GENERATOR BEHAVIOR DURING A PROCEDURE AND NO ERROR MESSAGES DISPLAYED. SOLUTION FOR THIS EVENT IS UNKNOWN, BUT NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971533 MAESTRO 4000 CONTROLLER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER LPB BOSTON SCIENTIFIC CORPORATION 86248 0702191233 08714729861911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown