BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1913912 · Received December 3, 2010

    Report

    Report Number
    3005099803-2010-05040
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODE RETURNED WITH THE ARRAY EXTENDED. A VISUAL EXAMINATION FOUND THAT THE ARRAY WAS SLIGHTLY CRUSHED AND THE TINES WERE NOT EVENLY SPACED AND WERE DEFORMED. FUNCTIONALLY, WHEN THE ARRAY WAS PARTIALLY RETRACTED, TWO OF THE WIRES CROSSED. THE WIRES THEN RELEASED AND UNCROSSED WHEN THE ARRAY WAS FULLY EXTENDED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE ARRAY WAS DEFORMED. THE EVALUATION FOUND THAT THE ELECTRODE RETURNED WITH THE ARRAY EXTENDED WHICH MAY HAVE LED TO THE DAMAGE. ADDITIONALLY, DURING MANUFACTURING, THE ELECTRODE ARRAYS ARE 100% INSPECTED FOR DEFECTS. SINCE THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE ELECTRODE WAS ADVANCED TO THE TARGET LESION UNDER ULTRASOUND GUIDANCE. HOWEVER, WHEN EXTENDED, THE SHAPE DID NOT APPEAR TO BE SYMMETRICAL. THE ELECTRODE WAS WITHDRAWN FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN NEEDLE ELECTRODE. THE ACCOUNT NOTED THAT PRIOR TO USE NO DAMAGE WAS VISIBLE TO THE ELECTRODE. 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 WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE ELECTRODE WAS ADVANCED TO THE TARGET LESION UNDER ULTRASOUND GUIDANCE. HOWEVER, WHEN EXTENDED, THE SHAPE DID NOT APPEAR TO BE SYMMETRICAL. THE ELECTRODE WAS WITHDRAWN FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN NEEDLE ELECTRODE. THE ACCOUNT NOTED THAT PRIOR TO USE NO DAMAGE WAS VISIBLE TO THE ELECTRODE. 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 WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262280 11405138

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR