BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROUND PAD VALLEY LAB

    MDR report key: 2432327 · Received January 30, 2012

    Report

    Report Number
    3005099803-2012-00250
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    IKD
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER (181752) COULD NOT BE MATCHED TO THE REPORTED DEVICE (B)(4). THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2012-00250 FOR THE PATIENT RETURN GROUNDING PAD, MANUFACTURER REPORT # 3005099803-2012-00258 FOR THE LEVEEN NEEDLE ELECTRODE AND MANUFACTURER REPORT # 3005099803-2012-00251 FOR THE RF 3000 RADIOFREQUENCY GENERATOR. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE, A RF 3000 RADIOFREQUENCY GENERATOR AND A PATIENT RETURN GROUNDING PAD WERE USED DURING A LIVER RADIOFREQUENCY ABLATION PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD HEPATOCELLULAR CARCINOMA, WITH AN 11X9X8CM TUMOR IN THE CRANIAL PORTION OF THE RIGHT LIVER LOBE. REPORTEDLY, THE ABLATION TOOK 3.5 HOURS TO COMPLETE. AT THE END OF THE PROCEDURE, DURING REMOVAL OF THE GROUNDING PADS, A SINGLE BURN WAS DISCOVERED ON THE PATIENT'S LEFT THIGH. THE SECOND DEGREE BURN WAS TREATED WITH A WOUND BANDAGE. DESPITE THE BURN, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION POST PROCEDURE. ADDITIONAL FOLLOW UP CONFIRMED THAT THE PAD BURN HAD RESOLVED, AND THE PATIENT LEFT THE HOSPITAL IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROUND PAD VALLEY LAB CABLE, ELECTRODE IKD BOSTON SCIENTIFIC - MARLBOROUGH M0043540

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention (B)(4) GENERATOR