BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 3000¿ CARDIAC ABLATION SYSTEM - CONTROLLER

    MDR report key: 2415894 · Received January 13, 2012

    Report

    Report Number
    2134265-2012-00282
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    GXD
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WAS NO VISIBLE DAMAGE. THE TAMPER PROOF SEAL WAS PRESENT BUT BROKEN. THE MAESTRO CONTROLLER PASSED POWER-ON SELF-TEST AND ALL STEPS OF ITS FINAL TEST THAT COULD BE PERFORMED WITHOUT REMOVAL OF THE DEVICE'S COVER. ADDITIONAL CYCLES OF RADIO FREQUENCY (RF) DELIVERY ON/OFF WERE PERFORMED WHILE MONITORING THE RF OUTPUT ACROSS THE CONNECTED TEST LOAD AND THE MAESTRO CONTROLLER FRONT PANEL DISPLAY. RF ON/OFF DELIVERY CYCLES WERE REPEATED OVER A FIFTEEN MINUTE PERIOD WITH GREATER THAN 20 CYCLES COMPLETED. THERE WAS NO PROBLEM STARTING OR STOPPING RF USING THE MAESTRO CONTROLLER RF POWER CONTROL BUTTON. RF OUTPUT WAS TERMINATED EACH TIME WHEN THE MAESTRO CONTROLLER RF POWER CONTROL BUTTON WAS DEPRESSED. ENVIRONMENTAL STRESS TESTING WAS PERFORMED (WHICH INCLUDED LOW AND HIGH TEMPERATURE, AND HIGH AND LOW LINE VOLTAGES) WITH NO OCCURRENCE OF THE REPORTED ISSUE. DURING ENVIRONMENTAL TESTING AT EACH OF THESE CONDITIONS, RF DELIVERY TESTING WAS PERFORMED AND RF OUTPUT WAS SUCCESSFULLY STARTED AND STOPPED EACH TIME USING THE RF POWER CONTROL BUTTON ON THE MAESTRO CONTROLLER. THE EXTERNAL MANUFACTURER ALSO VERIFIED THAT RF DELIVERY SUCCESSFULLY STOPPED AFTER THE ABLATION SET DURATION TIMED OUT. THE EXTERNAL MANUFACTURER PERFORMED VISUAL INSPECTION OF THE MAESTRO CONTROLLER WITH THE TOP ENCLOSURE REMOVED. NOTHING WAS FOUND DURING VISUAL INSPECTION OF THE DEVICE THAT COULD ACCOUNT FOR THE REPORTED ISSUE. VISUAL INSPECTION OF THE MAESTRO CONTROLLER RF POWER CONTROL BUTTON WAS PERFORMED. THE EXTERNAL MANUFACTURER REMOVED THE RF POWER CONTROL SWITCH HARNESS ASSEMBLY FROM THE MAESTRO CONTROLLER AND PERFORMED VISUAL INSPECTION. NO DAMAGE WAS NOTED TO THE CLEAR LENS CAP OR THE INNER WALLS OF THE BUTTON HOUSING ASSEMBLY. THERE WAS NO EVIDENCE OF RESTRICTED MOVEMENT OR STICKING OF THE RF POWER CONTROL DURING ANY OF THE TESTING PERFORMED BY THE EXTERNAL MANUFACTURER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGICAL (EP) ABLATION PROCEDURE, THE RADIO FREQUENCY (RF) POWER CONTROL BUTTON WAS INTERMITTENTLY STICKING. DURING THE PROCEDURE THE BUTTON LOCATED ON THE FRONT OF THE MACHINE THAT CONTROLS THE DELIVERY OF THE RF THERAPY WAS INTERMITTENTLY STICKING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGICAL (EP) ABLATION PROCEDURE, THE RADIO FREQUENCY (RF) POWER CONTROL BUTTON WAS INTERMITTENTLY STICKING. DURING THE PROCEDURE THE BUTTON LOCATED ON THE FRONT OF THE MACHINE THAT CONTROLS THE DELIVERY OF THE RF THERAPY WAS INTERMITTENTLY STICKING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO 3000¿ CARDIAC ABLATION SYSTEM - CONTROLLER GENERATOR, LESION, RADIOFREQUENCY GXD BOSTON SCIENTIFIC - SAN JOSE M00421000TC0 030211024M

    Patients

    Seq Age Sex Outcome Treatment
    1