BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 2111658 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01864
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01863 AND 3005099803-2011-01865 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR, A LEVEEN NEEDLE ELECTRODE AND A PATIENT RETURN GROUNDING PAD WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, AN OPEN SURGICAL PROCEDURE, LOBECTOMY COMBINED WITH RFA, WAS PERFORMED. AFTER COMPLETING THE LOBECTOMY, THE ABLATION WAS PERFORMED. THE INITIAL TREATMENT WAS ADMINISTERED ON A 4CM LIVER LESION. IF THE BURN WAS SUCCESSFUL, TWO ADDITIONAL SITES WERE TO BE ABLATED. HOWEVER, AFTER APPROXIMATELY 30 MINUTES, A GENERATOR ERROR MESSAGE (E03) OCCURRED. THE ABLATION WAS STOPPED, THE GENERATOR WAS RESET, AND THE ABLATION TREATMENT WAS CONTINUED. SUBSEQUENTLY, A SECOND GENERATOR ERROR (P01) OCCURRED. THE CORRESPONDING PATIENT RETURN GROUNDING PAD (PAD 1) WAS REPLACED AND THE ABLATION WAS CONTINUED. AFTER A TOTAL TREATMENT TIME OF APPROXIMATELY 90 MINUTES, ROLL-OFF HAD NOT BEEN ACHIEVED SO THE ABLATION PROCEDURE WAS ABORTED BY THE PHYSICIAN AND THE TUMORS WERE REMOVED SURGICALLY. REPORTEDLY, THERE WERE NO VISIBLE ISSUES WITH THE LEVEEN NEEDLE ELECTRODE. ADDITIONALLY, THERE WERE NO SIGNS THAT THE TISSUE HAD BEEN ABLATED. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262160 14245022

    Patients

    Seq Age Sex Outcome Treatment
    1