BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1944259 · Received January 3, 2011

    Report

    Report Number
    3005099803-2010-05363
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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)

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE ARRAY TO BE FULLY EXTENDED UPON RECEIPT. THE ARRAY TINES WERE NOT EVENLY SPACED AND WERE FOUND TO BE SLIGHTLY DEFORMED. IT IS NOT KNOWN IF THIS DAMAGE OCCURRED DURING SHIPPING OR WHILE THE ACCOUNT PREPARED THE DEVICE FOR USE. A FUNCTIONAL EVALUATION WAS PERFORMED BY RETRACTING AND EXTENDING THE ARRAY; NONE OF THE TINES WERE FOUND TO CROSS. ADDITIONALLY, NO RESISTANCE WAS ENCOUNTERED WHILE ACTUATING THE ARRAY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE ARRAY TINES WERE CROSSED. THE ARRAY WAS ACTUATED MULTIPLE TIMES, BUT FAILED TO REPRODUCE THE REPORTED FAILURE. ADDITIONALLY, ARRAYS ARE 100% INSPECTED FOR CROSSED WIRES. THE COMPLAINT WAS NOT CONFIRMED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A HCC TO LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER UNPACKING THE ELECTRODE, SEVERAL TINES WERE FOUND TO BE HOOKED/CROSSED OVER THEIR ADJACENT TINES. AS A RESULT, WHEN EXTENDED, THE ARRAY FAILED TO PRODUCE THE UNIFORM UMBRELLA SHAPE. THE TINES WERE ABLE TO BE UNHOOKED, BUT WHEN THE ARRAY WAS RETRACTED, THEN RE-EXTENDED, THE SAME ISSUE RECURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A HCC TO LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER UNPACKING THE ELECTRODE, SEVERAL TINES WERE FOUND TO BE HOOKED/CROSSED OVER THEIR ADJACENT TINES. AS A RESULT, WHEN EXTENDED, THE ARRAY FAILED TO PRODUCE THE UNIFORM UMBRELLA SHAPE. THE TINES WERE ABLE TO BE UNHOOKED, BUT WHEN THE ARRAY WAS RETRACTED, THEN RE-EXTENDED, THE SAME ISSUE RECURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. 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 ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262240 12651932

    Patients

    Seq Age Sex Outcome Treatment
    1