BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEEN COACCESS ELECTRODE SYSTEM

    MDR report key: 1038152 · Received May 6, 2008

    Report

    Report Number
    3005099803-2008-00424
    Event Type
    Death
    Date Received
    May 6, 2008
    Date of Event
    September 27, 2007
    Report Date
    October 2, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOS
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVAL WAS NOT PERFORMED. THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNDETERMINED. SINCE THE CUSTOMER WAS UNABLE TO SUPPLY THE LOT NUMBER OF THE PERTINENT DEVICE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE SEPTEMBER 2007 15-MONTH RF PROBE PRODUCT FAMILY TREND CHART WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    ON OCTOBER 02, 2007, BOSTON SCIENTIFIC CORP WAS INFORMED THAT A RADIO FREQUENCY ABLATION PROCEDURE WAS PERFORMED ON APPROX A WEEK EARLIER, USING A COACCESS NEEDLE ELECTRODE SYSTEM DEVICE (MALE PT). IT WAS REPORTED THAT ABLATIONS "... WERE PERFORMED ON THREE PARTS ON A LIVER. THE MULTIPLE DEPLOYMENT METHOD WAS USED RESPECTIVELY. ALSO, ALL ABLATIONS WERE PERFORMED ROLL-OFF. AFTER THAT, HEMOSTASIS WAS PERFORMED AT SURFACE OF THE LIVER BY ABLATION AT 20W AND THE PROCEDURE WAS COMPLETED. HOWEVER, THE BLOOD PRESSURE BECAME INCREASE. SINCE A BLEEDING WAS FOUND AT AP (ARTERIAL-PULMONARY) SHUNT UNDER THE ANGIOGRAPHY, THE EMBOLIZATION WAS SUCCESSFULLY PERFORMED. ALSO, PEIT (PERCUTANEOUS ETHANOL INJECTION THERAPY) WAS SUCCESSFULLY PERFORMED FOR THE EMBOLIZATION OF THE PORTAL VEIN. HOWEVER, THE PT PASSED AWAY THE FOLLOWING DAY. THE PHYSICIAN THOUGHT THAT THIS EVENT WASN'T PRODUCT RELATED." ADDITIONAL EVENT DETAILS PROVIDED INCLUDED: FOUR PT GROUNDING PADS WERE USED, PATIENT PREP WAS PERFORMED ACCORDING TO THE DFU, HOWEVER, THE PROCEDURE ALGORITHM WAS NOT FOLLOWED; MULTIPLE DEPLOYMENT METHOD WAS USED FOR THE PROCEDURE. THE TOTAL APPLIED ENERGY TIME WAS ESTIMATED AT ABOVE 15 MINUTES WITH THE MAXIMUM APPLIED ENERGY WAS "MIGHT BE UNDER 100W." THE INTENDED ABLATION WAS SUCCESSFULLY COMPLETED AND ROLL-OFF WAS ACHIEVED. THE FOLLOWING ADDITIONAL PT DETAILS WERE ASCERTAINED FROM THE USER: NO ANOMALY WAS NOTED ON THE BLOOD CHECK. PATIENT VALUE: 60%; NO COMPLICATION WAS OBSERVED ON HCC; TUMOR DATA: STAGE 1, DIAMETER OF TUMOR WAS 1 CM., CIRRHOSIS TYPE: CHILD B; THE PATIENT HAD A TREATMENT BY RFA AND TAE ON APPROX SEVEN MONTHS PRIOR TO ORIGINAL MONTH. ADDITIONAL INFO ASCERTAINED INDICATED THAT THE PHYSICIAN COMMENTED "...THE PRODUCT UNRELATED. NO ANOMALY WAS NOTED DURING THE PROCEDURE. ALSO, IT MIGHT BE AP SHUNT WHICH WAS UNABLE TO SEE UNDER THE ECHO." ALSO, HE THOUGHT "...A BLEEDING WASN'T CAUSED BY HANDLING ERROR." THE PATIENT HAD DIC, DIFFUSE INTRAVASCULAR COAGULATION; THEREFORE, HE PASSED AWAY DUE TO "MOF; MULTIPLE ORGAN FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN COACCESS ELECTRODE SYSTEM JOS BOSTON SCIENTIFIC CORPORATION M001262220 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death