BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 3000¿ CARDIAC ABLATION SYSTEM - CONTROLLER

    MDR report key: 2491589 · Received March 14, 2012

    Report

    Report Number
    2134265-2012-01578
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    GXD
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED: DEVICE LOT NUMBER FROM 21711017M TO 102209024M. DEVICE EXPIRATION DATE FROM 18-JUN-2038 TO 15-FEB-2037. DEVICE MANUFACTURED DATE FROM 02-MARCH-2011 TO 30-NOV-2009. DEVICE EVALUATED BY MFR: ONLY MINOR COSMETIC DAMAGE (PAINT CHIPS, SCRATCHES) WAS NOTED ON THE MAESTRO CONTROLLER TOP COVER DURING INCOMING SERVICE INSPECTION. THE TAMPER PROOF SEAL WAS PRESENT BUT BROKEN. UPON RECEIPT OF THE MAESTRO CONTROLLER, IT PASSED POWER-ON SELF-TEST AND ALL STEPS OF ITS FINAL TEST THAT COULD BE PERFORMED WITHOUT REMOVAL OF THE DEVICE'S COVER (EXCLUDING BURN-IN, CALIBRATION, AND HI-POT). RF DELIVERY TESTING WAS PERFORMED WITH CUSTOMER'S MEMORY 1 TO MEMORY 5 SETTINGS WITH NO PROBLEM FOUND. REVIEW OF THE MAESTRO CONTROLLER SERVICE CODE HISTORY LOG REVEALED THAT A D04(00) DIAGNOSTIC CODE WAS REPORTED WHILE THE DEVICE WAS IN THE CUSTOMER'S POSSESSION. A D04-TEMP ABOVE SETPOINT DIAGNOSTIC CODE OCCURS DURING RF DELIVERY IN TEMPERATURE CONTROL MODE WHEN THE DISPLAYED TEMPERATURE IS GREATER THAN THE SETPOINT BY AT LEAST 5°C FOR MORE THAN 4 SECONDS. RF DELIVERY IS HALTED WHEN A DIAGNOSTIC CODE IS DISPLAYED ON THE MAESTRO CONTROLLER. DURING RF DELIVERY TESTING, A HEAT GUN WAS USED TO HEAT THE CATHETER TIP ABOVE THE TEMPERATURE SETPOINT BY AT LEAST 5°C. UPON EXCEEDING THE TEMPERATURE SETPOINT, IT WAS VERIFIED THAT THE MAESTRO CONTROLLER DISPLAYED A D04-TEMP ABOVE SETPOINT DIAGNOSTIC CODE AND HALTED RF DELIVERY AS EXPECTED. ENVIRONMENTAL STRESS TESTING WAS PERFORMED (WHICH INCLUDED LOW AND HIGH TEMPERATURE, AND LOW AND HIGH VOLTAGE MARGIN TESTS) WITH NO OCCURRENCE OF THE CUSTOMER'S COMPLAINT. DURING ENVIRONMENTAL TESTING AT THESE CONDITIONS, STELLARTECH VERIFIED THAT THE MAESTRO CONTROLLER PROPERLY HALTED RF DELIVERY AND DISPLAYED AN APPROPRIATE DIAGNOSTIC CODE ERROR WHEN TEMPERATURE EXCEEDED THE SETPOINT. STELLARTECH PERFORMED VISUAL INSPECTION OF THE MAESTRO CONTROLLER WITH THE TOP ENCLOSURE REMOVED. ALL HARDWARE AND HARNESSES WERE SECURELY ATTACHED. NOTHING WAS FOUND DURING VISUAL INSPECTION OF THE DEVICE THAT COULD ACCOUNT FOR THE CUSTOMER'S COMPLAINT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS UNABLE TO BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2012-01603. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION TREATMENT PROCEDURE, A TEMPERATURE CONTROL ISSUE AND CHAR OCCURRED. THE BLAZER II XP CATHETER WAS INSERTED VIA THE LEFT FEMORAL VEIN. THE TREATMENT SITE WAS THE CAVO-TRICUSPID ISTHMUS (CTI) IN THE RIGHT ATRIUM. THE MAESTRO 3000 RF CARDIAC ABLATION GENERATOR WAS SET AT 65 DEGREES FOR 120 SECONDS, HOWEVER, THE UNIT EXCEEDED 80 DEGREES AND THE AUTOMATIC SHUTOFF DID NOT OPERATE CORRECTLY. UPON REMOVAL OF THE BLAZER II XP CATHETER, CHAR WAS NOTED. THE TEMPERATURE WAS TURNED DOWN MANUALLY, AND THE PROCEDURE WAS COMPLETED WITH THE SAME SYSTEM WITH A DIFFERENT CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2012-01603. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION TREATMENT PROCEDURE, A TEMPERATURE CONTROL ISSUE AND CHAR OCCURRED. THE BLAZER II XP CATHETER WAS INSERTED VIA THE LEFT FEMORAL VEIN. THE TREATMENT SITE WAS THE CAVO-TRICUSPID ISTHUMUS (CTI) IN THE RIGHT ATRIUM. THE MAESTRO 3000 RF CARDIAC ABLATION GENERATOR WAS SET AT 65 DEGREES FOR 120 SECONDS, HOWEVER THE UNIT EXCEEDED 80 DEGREES AND THE AUTOMATIC SHUTOFF DID NOT OPERATE CORRECTLY. UPON REMOVAL OF THE BLAZER II XP CATHETER, CHAR WAS NOTED. THE TEMPERATURE WAS TURNED DOWN MANUALLY, AND THE PROCEDURE WAS COMPLETED WITH THE SAME SYSTEM WITH A DIFFERENT CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2012-01603. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION TREATMENT PROCEDURE, A TEMPERATURE CONTROL ISSUE AND CHAR OCCURRED. THE BLAZER II XP CATHETER WAS INSERTED VIA THE LEFT FEMORAL VEIN. THE TREATMENT SITE WAS THE CAVO-TRICUSPID ISTHMUS (CTI) IN THE RIGHT ATRIUM. THE MAESTRO 3000 RF CARDIAC ABLATION GENERATOR WAS SET AT 65 DEGREES FOR 120 SECONDS, HOWEVER THE UNIT EXCEEDED 80 DEGREES AND THE AUTOMATIC SHUTOFF DID NOT OPERATE CORRECTLY. UPON REMOVAL OF THE BLAZER II XP CATHETER, CHAR WAS NOTED. THE TEMPERATURE WAS TURNED DOWN MANUALLY, AND THE PROCEDURE WAS COMPLETED WITH THE SAME SYSTEM WITH A DIFFERENT CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 102209024M

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR