BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 4000 CONTROLLER

    MDR report key: 16808518 · Received April 25, 2023

    Report

    Report Number
    2124215-2023-15835
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    March 1, 2023
    Report Date
    October 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LPB
    UDI-DI
    08714729861911
    PMA / PMN Number
    P920047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PREMARKET / 510(K) #'S: P980003, P020025. THE MAESTRO 4000 CONTROLLER WAS RETURNED AND ANALYZED BY THE SFMD. THE RETURNED DEVICE ANALYSIS SHOWED NO EVIDENCE OF DEFECT, MALFUNCTION OR DAMAGE UPON VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED ERROR COULD NOT BE REPRODUCED, SO THE REPORTED EVENT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PREMARKET / 510(K) #'S: P980003, P020025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GENERATOR CONTROLLER EXHIBITED LOW POWER. DURING A PROCEDURE A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. THE GENERATOR UNIT WAS NOT GETTING TO MAX TEMPERATURE AND WAS STAYING AT LOW POWER. MULTIPLE CATHETERS WERE ATTEMPTED TO BE USED WITH THE EQUIPMENT, BUT THE ISSUE REMAINED. THE CONTROLLER WAS REPLACED WITH A DIFFERENT MODEL DEVICE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE CONTROLLER HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GENERATOR CONTROLLER EXHIBITED LOW POWER. DURING A PROCEDURE A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. THE GENERATOR UNIT WAS NOT GETTING TO MAX TEMPERATURE AND WAS STAYING AT LOW POWER. MULTIPLE CATHETERS WERE ATTEMPTED TO BE USED WITH THE EQUIPMENT, BUT THE ISSUE REMAINED. THE CONTROLLER WAS REPLACED WITH A DIFFERENT MODEL DEVICE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE CONTROLLER HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200797 MAESTRO 4000 CONTROLLER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER LPB BOSTON SCIENTIFIC CORPORATION 86248 0206170414 08714729861911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown