BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 4000 POD, 100W

    MDR report key: 17564557 · Received August 17, 2023

    Report

    Report Number
    2124215-2023-43949
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 17, 2023
    Manufacturer
    STELLARTECH RESEARCH CORPORATION
    Product Code
    LPB
    UDI-DI
    08714729861966
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) # P920047, 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

    DURING AN ABLATION PROCEDURE, A MAESTRO 4000 POD WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING PROCEDURE THE DEVICE KEPT SHUTTING OFF DUE TO LOW TEMPERATURE WARNINGS. THIS HAPPENED AFTER SEVERAL ABLATIONS PERFORMED SUCCESSFULLY. WHEN THE PHYSICIAN WANTED TO APPLY HIGHER POWER AT 40W, THE GENERATOR WOULD STOP ABLATION RIGHT AFTER HIGH POWER WAS SET. THE STARTING TEMPERATURES DURING THE ERRORS WAS AVERAGING 23 DEGREES. THE HIGHER FLOW RATE FROM THE METRIQ PUMP WOULD RESULT IN THE TEMPERATURE DROPPING TO 15 DEGREES RAPIDLY. THE PHYSICIAN COULD NOT ABLATE AT HIS DESIRED POWERS. THE POD WAS PULLED FROM UNDER THE PATIENT DRAPE. THE PHYSICIAN ENDED THE PROCEDURE BEFORE ANY MORE TROUBLESHOOTING STEPS COULD BE ATTEMPTED. PATIENT COMPLICATIONS ARE UNKNOWN AS WELL AS PRODUCT RETURN. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737320 MAESTRO 4000 POD, 100W CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER LPB STELLARTECH RESEARCH CORPORATION 86258 0116201017 08714729861966

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown