BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    MDR report key: 1994022 · Received February 16, 2011

    Report

    Report Number
    3005099803-2011-00440
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPORTED THAT THE ABLATION TREATMENT WAS SUCCESSFUL AND THAT ROLL-OFF WAS ABLE TO BE ACHIEVED, BUT THAT THE ABLATED AREA APPEARED SMALLER THAN THE SIZE DESIRED. THEREFORE, THIS EVENT HAS BEEN DEEMED NON MDR-REPORTABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    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)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: EACH OF THE TWO ROUNDS OF ABLATION TREATMENT ADMINISTERED AT THE FIRST LIVER TUMOR LOCATION ENDED WITH ROLL-OFF BEING ACHIEVED. AFTER THE SECOND ROUND OF TREATMENT, ANOTHER ECHO SCAN WAS PERFORMED WHICH CONFIRMED THAT THE ABLATION HAD BEEN SUCCESSFUL. HOWEVER, THE ACCOUNT REPORTED THAT THE ABLATED AREA APPEARED SMALLER THAN THE SIZE DESIRED. ADDITIONALLY, THE ACCOUNT VERIFIED THAT THE ARRAY WAS ABLE TO BE FULLY EXTENDED WHILE INSIDE THE PATIENT, BUT NOTED THAT SOME DIFFICULTY WAS ENCOUNTERED WHILE FIRST ATTEMPTING TO EXTEND THE ARRAY AT THE BEGINNING OF THE PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. FOLLOW-UP INFORMATION ON (B)(6), 2011 REVEALED A SECOND FAILURE MODE (INSUFFICIENT ROLL-OFF). A NEW FILE WAS CREATED TO ADDRESS THE GENERATOR USED IN THE PROCEDURE (SEE MFR. REPORT # 3005099803-2011-00440). MANUFACTURER REPORT # 3005099803-2011-00307 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN COACCESS ELECTRODE SYSTEM WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, EACH ABLATION TREATMENT WAS PERFORMED IN FOUR STEPS. THE TREATMENT BEGAN WITH THE ARRAY EXTENDED ABOUT ONE QUARTER AND WITH EACH SUCCESSIVE STEP THE ARRAY WAS EXTENDED ONE QUARTER FURTHER UNTIL FULLY EXTENDED. AFTER COMPLETING THE INITIAL TREATMENT, THE ACCOUNT WAS UNABLE TO VERIFY CAUTERIZATION UNDER ECHO SO A SECOND ROUND OF TREATMENT WAS ADMINISTERED AT THE SAME LIVER LOCATION. IT IS NOT KNOWN IF THE INABILITY TO CONFIRM CAUTERIZATION REVEALED AN ISSUE WITH THE IMAGING SYSTEM OR THE FINAL ABLATION SIZE. THE ELECTRODE WAS THEN REMOVED FROM THE PATIENT. HOWEVER, UPON REMOVAL, THE ELECTRODE WAS TESTED AND THE ARRAY COULD ONLY BE EXTENDED ABOUT ONE THIRD. A SECOND LEVEEN COACCESS ELECTRODE SYSTEM WAS USED TO COMPLETE THE ABLATION AT THE SECOND LIVER TUMOR LOCATION WITH THE SAME RF 3000 RADIOFREQUENCY GENERATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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