BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    MDR report key: 1842968 · Received September 23, 2010

    Report

    Report Number
    3005099803-2010-04022
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE SERIAL NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES. ENVIRONMENTAL STRESS TESTING, UNDER CONDITIONS OF HIGH AND LOW TEMPERATURE, HIGH AND LOW MARGIN (SUPPLY) VOLTAGE, AND SHORT-CIRCUIT SHUTDOWN, WAS PERFORMED. THE GENERATOR DID NOT EXHIBIT ANY MALFUNCTION WHICH COULD ACCOUNT FOR THE EVENT. FURTHERMORE, THE DEVICE PASSED ALL PERFORMANCE CRITERIA OF ITS FINAL TEST PROCEDURE. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. HOWEVER, INFORMATION RECEIVED NOTED THAT THE DEVICE WAS USED TO ABLATE BONE IN THE UPPER PART OF THE LEG. THE RF GENERATOR AND SOLOIST SINGLE NEEDLE ELECTRODE DIRECTIONS FOR USE (DFU) DESCRIBE THE GENERAL INDICATION OF SOFT TISSUE ABLATIONS WITH A SPECIFIC INDICATION FOR LIVER ABLATION. A BONE ABLATION IS CONSIDERED OFF-LABEL USE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04018 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A SOLOIST SINGLE NEEDLE ELECTRODE WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE OF THE LEG PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE ABLATION WAS PERFORMED IN THREE CYCLES OF 15 MINUTES. PRIOR TO BEGINNING THE TREATMENT, SALINE WAS INJECTED INTO THE AREA TO BE TREATED. THE FIRST TWO CYCLES WERE PERFORMED ACCORDING TO THE SPECIFIED ELECTRODE ALGORITHM. WHILE PERFORMING THE THIRD ABLATION CYCLE, THE POWER WAS INCREASED UP TO 43 WATTS AT WHICH POINT ROLL-OFF WAS ACHIEVED. HOWEVER, AT THE CONCLUSION OF THIS CYCLE, A PUNCTURE BURN WAS IDENTIFIED. THE ACCOUNT REPORTED THAT THE DISTAL END OF THE ELECTRODE APPEARED SLIGHTLY CHARRED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND GIVEN PAIN MEDICATION. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04018 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A SOLOIST SINGLE NEEDLE ELECTRODE WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE OF THE LEG PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE ABLATION WAS PERFORMED IN THREE CYCLES OF 15 MINUTES. PRIOR TO BEGINNING THE TREATMENT, SALINE WAS INJECTED INTO THE AREA TO BE TREATED. THE FIRST TWO CYCLES WERE PERFORMED ACCORDING TO THE SPECIFIED ELECTRODE ALGORITHM. WHILE PERFORMING THE THIRD ABLATION CYCLE, THE POWER WAS INCREASED UP TO 43 WATTS AT WHICH POINT ROLL-OFF WAS ACHIEVED. HOWEVER, AT THE CONCLUSION OF THIS CYCLE, A PUNCTURE BURN WAS IDENTIFIED. THE ACCOUNT REPORTED THAT THE DISTAL END OF THE ELECTRODE APPEARED SLIGHTLY CHARRED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND GIVEN PAIN MEDICATION. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04018 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A SOLOIST SINGLE NEEDLE ELECTRODE WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE OF THE LEG PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE ABLATION WAS PERFORMED IN THREE CYCLES OF 15 MINUTES. PRIOR TO BEGINNING THE TREATMENT, SALINE WAS INJECTED INTO THE AREA TO BE TREATED. THE FIRST TWO CYCLES WERE PERFORMED ACCORDING TO THE SPECIFIED ELECTRODE ALGORITHM. WHILE PERFORMING THE THIRD ABLATION CYCLE, THE POWER WAS INCREASED UP TO 43 WATTS AT WHICH POINT ROLL-OFF WAS ACHIEVED. HOWEVER, AT THE CONCLUSION OF THIS CYCLE, A PUNCTURE BURN WAS IDENTIFIED. THE ACCOUNT REPORTED THAT THE DISTAL END OF THE ELECTRODE APPEARED SLIGHTLY CHARRED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND GIVEN PAIN MEDICATION. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262200

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| O