BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1862734 · Received October 8, 2010

    Report

    Report Number
    3005099803-2010-04196
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) - EXENDED ABLATION ZONE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04197 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) 2010. ACCORDING TO THE COMPLAINANT, A 5 CM TUMOR WAS TO BE TREATED USING RADIOFREQUENCY ABLATION. THE ABLATION WAS TO ENCOMPASS THE S4, S5, AND S8 SEGMENTS OF THE LIVER AND PART OF THE PANCREAS. PRIOR TO PERFORMING THE ABLATION, PERCUTANEOUS ETHANOL INJECTION THERAPY (PEIT) WAS PERFORMED AT THE ABLATION SITE. THE TUMOR WAS THEN ABLATED FOR A DURATION OF 8 MINUTES WITH ROLL-OFF BEING ACHIEVED AT THAT TIME. HOWEVER, POST PROCEDURE, THE ABLATION ZONE APPEARED TO BE LARGER THAN THAT WHICH WOULD BE EXPECTED FOR THE ELECTRODE USED. ADDITIONALLY, THE SITE INDICATED THAT THE PATIENT SUSTAINED A PUNCTURE-SITE BURN FROM THE ELECTRODE. IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO THE INSULATION ON THE ELECTRODE. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT ENCOUNTERED LIVER DYSFUNCTION, BILIRUBIN/CRP INCREASES, AND PANCREATITIS. THE ACCOUNT FURTHER REVEALED THAT THE PATIENT HAS BEEN IN ICU AND IS IMPROVING. IT IS UNKNOWN IF THE PUNCTURE-SITE BURN REQUIRED TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION - THE LEVEEN COACCESS ELECTODE SYSTEM WAS USED WITH A PLASTIC NEEDLE GUIDE MANUFACTURED BY HITACHI MEDICAL. THE INTRODUCER WAS USED WITH THE ELECTRODE AND WAS INSERTED AT AN ANGLE TO THE ABLATION SITE. DURING THE PROCEDURE, THE PROGRESSION OF THE ABLATION WAS MONITORED UNDER ECHO. CORRECTED INFORMATION - WAS: THE ABLATION WAS TO ENCOMPASS THE S4, S5, AND S8 SEGMENTS OF THE LIVER AND PART OF THE PANCREAS. SHOULD BE: THE ABLATION WAS TO ENCOMPASS THE S8 SEGMENT AND PART OF THE S4 LIVER SEGMENT AT A DEPTH OF 3 TO 4 CENTIMETERS FROM THE LIVER SURFACE. THE TUMOR DIAMETER WAS 4.5 CENTIMETRES. HOWEVER, UNINTENDED ABLATION OCCURED TO THE S5 LIVER SEGMENT AND PART OF THE PANCREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262240

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O