BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOFREQUENCY ABLATION GENERATOR

    MDR report key: 2923265 · Received April 3, 2006

    Report

    Report Number
    6000037-2006-00103
    Event Type
    Injury
    Date Received
    April 3, 2006
    Date of Event
    March 8, 2006
    Report Date
    March 8, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    JOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: UNKNOWN/NO INFORMATION AVAILABLE FROM USER FACILITY. RELEVANT TESTS: UNKNOWN/NO INFORMATION AVAILABLE FROM USER FACILITY. THIS RADIOFREQUENCY GENERATOR WAS IMPORTED BY A DISTRIBUTOR IN (B)(4) NAMED (B)(4) BEFORE BSC'S ACQUISITION OF RADIOTHERAPEUTICS. NO LOT NUMBER WAS AVAILABLE FOR THIS DEVICE, CONSEQUENTLY, THE EXPIRATION DATE OF THE DEVICE IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN/NO INFORMATION AVAILABLE FROM USER FACILITY. (B)(6). (B)(4). SURGICAL PROCEDURE ADDITIONAL. NO LOT NUMBER OF THIS DEVICE WAS AVAILABLE, CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. THE COMPLAINANT REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS THE DEVICE WAS DISCARDED AT THE FACILITY. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECIFICATIONS. SHOULD FURTHER DETAILS BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIANS WERE TREATING A (B)(6) FEMALE PATIENT WHO SUFFERED A METASTASES SUBMAXILLARY ADENOCYSTIC CARCINOMA, WITH LOCAL RESECTION AND PULMONARY METASTASECTOMY PERFORMED IN 2004. ON (B)(6) 2006 THE PATIENT UNDERWENT RADIOFREQUENCY ABLATION (RFA) OF A DOUBLE TUMOR WITH 2 HEPATIC LESIONS AND ANOTHER IN SEGMENT VII (4CM OF SUPERFICIAL DIAMETER). TWO GROUNDING PADS WERE PLACED ON THE LATERAL-INFERIOR REGION OF THE LEG. THE CABLES WERE CONNECTED TO EACH PAD, THEN AN INCISION WAS MADE AND A LAPAROTOMY WAS PERFORMED TO EXPLORE THE LIVER. THE PROCEDURE CONFIRMED THE PRESENCE OF 2 HEPATIC LESIONS AND AN RFA WAS PERFORMED. THE ABLATION OF THE MINOR LESIONS WAS PERFORMED WITH A 3.5 CM NEEDLE FINALIZING THE ABLATION IN 2 SESSIONS. THE SECOND SESSION WAS 8 MINUTES LONG WITH ROLL-OFF. THE MAJOR LESION REQUIRED 5 SESSIONS, COMPROBATING THAT THE LOCAL TEMPERATURE HAD INCREASED, BUT ROLL-OFF WAS NOT REACHED. IT WAS NOTED THAT THE DEVICE ALARM DID NOT ADVISE OF ANY PROBLEM DURING THE PROCEDURE. CORPORAL TEMPERATURE DID NOT INCREASE DURING THE PROCEDURE. AFTER FINALIZING THE PROCEDURE, AN ERYTHEMATOUS LESION WAS EVIDENT WITH PHYCTENAS 7 CM IN DIAMETER AND 4 CM OF CENTRAL ESCHARA IN THE LOCATION OF WHERE THE PAD HAD BEEN PLACED ON INFERIOR THIRD OF THE RIGHT LEG. THE BURN WAS REPORTED TO HAVE A SECOND DEGREE BURN, 10 TO 12 CM IN DIAMETER, WITH 5 CM OF NECROSIS AND WITH REDNESS AND BLISTERING. THE COMPLAINANT INDICATED THAT THE BURN NECESSITATED A SKIN GRAFT BE PERFORMED ON THE PATIENT. THE RFA PROCEDURE WAS REPORTED TO HAVE TAKEN A TOTAL OF 97 MINUTES. AFTER THE PROCEDURE WAS COMPLETED A BURN WAS NOTED ON THE LATERAL INFERIOR PORTION OF THE RIGHT LG WHERE GROUNDING PADS WERE PLACED. THE BURN WAS REPORTED AS A SECOND DEGREE BURN, SIZED AS 7CM BY 4 CM WITH CENTRAL ESCHAR. THE COMPLAINANT INDICATED THAT DURING THE PROCEDURE THE GENERATOR DID NOT ALARM AND THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS REQUIRING SKIN GRAFTS TO THE SUSTAINED BURNS AS A RESULT OF THE REPORTED EVENT. THE RFA PROCEDURE WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOFREQUENCY ABLATION GENERATOR GENERATOR JOS BOSTON SCIENTIFIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other