BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 3000¿ CARDIAC ABLATION SYSTEM - CONTROLLER

    MDR report key: 2071171 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01540
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: MID (B)(6) (YEARS). (B)(4). (B)(6). 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. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THERE WERE NO BROKEN OR MISSING PARTS FOUND DURING INCOMING SERVICE INSPECTION AT STELLARTECH. VISUAL INSPECTION NOTED THAT THE DEVICE COVER WAS DIRTY AND WITH SOME SCRATCHES PAINT CHIPS NOTED. VISUAL INSPECTION ALSO NOTED A STICKY RESIDUE MATERIAL ON THE CLEAR LENS CAP OF THE RF POWER CONTROL BUTTON. THE TAMPER PROOF SEAL WAS PRESENT BUT BROKEN. THE MAESTRO CONTROLLER UPON RECEIPT AT STELLARTECH PASSED THE POWER-ON SELF-TEST AND ALL STEPS OF ITS FINAL TEST THAT COULD BE PERFORMED WITHOUT REMOVAL OF THE DEVICE'S COVER. REVIEW OF THE MAESTRO CONTROLLER SERVICE CODE HISTORY DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER'S COMPLAINT. ENVIRONMENTAL STRESS TESTING WAS PERFORMED INCLUDING LOW AND HIGH TEMPERATURE, AND HIGH AND LOW LINE VOLTAGES, WITH NO ISSUES NOTED. DURING ENVIRONMENTAL TESTING AT THESE CONDITIONS, 60 CYCLES OF RF DELIVERY ON/OFF WERE PERFORMED AND RF DELIVERY WAS SUCCESSFULLY TERMINATED EACH TIME USING THE RF POWER CONTROL BUTTON ON THE MAESTRO CONTROLLER. ADDITIONAL CYCLES OF RF DELIVERY ON/OFF WERE PERFORMED WHILE MONITORING THE RF OUTPUT ACROSS THE TEST LOAD. MORE THAN 10 CYCLES OF RF DELIVERY WERE PERFORMED, WITH RF OUTPUT BEING TERMINATED EACH TIME WITH THE MAESTRO CONTROLLER RF POWER CONTROL BUTTON. ADDITIONAL RF DELIVERY WAS PERFORMED WITH A FOOT SWITCH ATTACHED TO THE MAESTRO CONTROLLER AND ALSO A MAESTRO REMOTE CONTROL TEST FIXTURE ATTACHED TO THE MAESTRO CONTROLLER. STELLARTECH WAS ABLE TO TERMINATE RF DELIVERY WITH EITHER THE FOOT SWITCH OR THE CONTROLLER RF POWER CONTROL BUTTON BOTH WHEN THE CONTROLLER WAS IN "ACTIVE" AND "INACTIVE" STATES. OUTPUT SIGNALS WERE VERIFIED CONFIRMING STOPPAGE OF RF DELIVERY. STELLARTECH 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 CUSTOMER'S COMPLAINT. VISUAL INSPECTION OF THE RF POWER CONTROL BUTTON NOTED SOME STICKY RESIDUE MATERIAL IN THE CENTER OF THE CLEAR LENS CAP OF THE RF POWER CONTROL BUTTON. PRIOR TO ANY DISASSEMBLY OF THE RF POWER CONTROL BUTTON ASSEMBLY, MULTIPLE ACTIVATIONS OF THE ASSEMBLY WERE PERFORMED BY PRESSING AROUND THE EDGES OF THE CIRCULAR LENS CAP AND ITS CENTER WHICH VERIFIED ITS CONTINUED SMOOTH UNRESTRICTED MOVEMENT. STELLARTECH REMOVED THE RF POWER CONTROL SWITCH HARNESS ASSEMBLY FROM THE MAESTRO CONTROLLER AND PERFORMED VISUAL INSPECTION. VISUAL INSPECTION OF THE CLEAR LENS CAP'S CIRCULAR SURFACE WALL AND INNER WALLS OF THE BUTTON HOUSING INDICATED NO RESIDUE AS OBSERVED ON THE CLEAR LENS CAP'S SURFACE. BOTH WALL SURFACES WERE SMOOTH WITHOUT NOTABLE DEFECTS. IN ADDITION, NEITHER SURFACE INDICATED ANY EVIDENCE OF CLEAR LENS CAP'S REMOVAL DURING USE BY CUSTOMER. NO VISIBLE DAMAGE TO THE ASSEMBLY WAS FOUND DURING VISUAL INSPECTION THAT COULD ACCOUNT FOR THE CUSTOMER'S COMPLAINT. DURING SERVICING, STELLARTECH REPLACED THE RF POWER CONTROL SWITCH HARNESS ASSEMBLY ON THE MAESTRO CONTROLLER. THE MAESTRO CONTROLLER PASSED ALL TESTING AT STELLARTECH. THE MANUFACTURING SERIAL NUMBER 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 ELECTROPHYSIOLOGY ABLATION TREATMENT PROCEDURE, THE POWER BUTTON ON THE CARDIAC ABLATION SYSTEM CONTROLLED FAILED. WHEN THE PHYSICIAN ATTEMPTED TO POWER OFF THE RADIO FREQUENCY (RF) SWITCH ON THE MAESTRO 3000 CARDIAC ABLATION SYSTEM CONTROLLER, THE RF BUTTON "STUCK" AND THE PHYSICIAN WAS UNABLE TO POWER OFF THE RF DELIVERED TO THE ABLATION CATHETER. ANOTHER MAESTRO GENERATOR WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY ABLATION TREATMENT PROCEDURE, THE POWER BUTTON ON THE CARDIAC ABLATION SYSTEM CONTROLLED FAILED. WHEN THE PHYSICIAN ATTEMPTED TO POWER OFF THE RADIO FREQUENCY (RF) SWITCH ON THE MAESTRO 3000 CARDIAC ABLATION SYSTEM CONTROLLER, THE RF BUTTON "STUCK" AND THE PHYSICIAN WAS UNABLE TO POWER OFF THE RF DELIVERED TO THE ABLATION CATHETER. ANOTHER MAESTRO GENERATOR WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO 3000¿ CARDIAC ABLATION SYSTEM - CONTROLLER GENERATOR, LESION, RADIOFREQUENCY LPB BOSTON SCIENTIFIC - SAN JOSE M00421000TCR0 073109041M

    Patients

    Seq Age Sex Outcome Treatment
    1