BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1951094 · Received January 6, 2011

    Report

    Report Number
    3005099803-2011-00028
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED WITH THE ARRAY FULLY RETRACTED. ADDITIONALLY, A LINE WAS NOTED AROUND THE CIRCUMFERENCE OF THE HANDLE PLUNGER. FUNCTIONALLY, THE ARRAY WAS ABLE TO BE EXTENDED AND RETRACTED. HOWEVER, RESISTANCE WAS ENCOUNTERED DURING ACTUATION. THE TINES OF THE ARRAY WERE FOUND TO BE UNEVENLY SPACED AND BENT. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE ARRAY WAS DEFORMED. HOWEVER, THE EVALUATION FOUND THE HANDLE PLUNGER HAD BEEN MARKED FOR PARTIAL DEPLOYMENT METHOD WHICH IS INDICATED FOR THE 5.0CM LEVEEN ELECTRODE ONLY. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER ERROR. 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 NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.(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 LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER EXTENDING THE ARRAY INTO THE LIVER METASTASIS, THE TINES WERE FOUND TO BE TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. THE ACCOUNT REPORTED THAT THE ELECTRODE WAS TESTED OUTSIDE THE PATIENT AND WORKED WITHOUT ISSUE. 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 LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, AFTER EXTENDING THE ARRAY INTO THE LIVER METASTASIS, THE TINES WERE FOUND TO BE TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. THE ACCOUNT REPORTED THAT THE ELECTRODE WAS TESTED OUTSIDE THE PATIENT AND WORKED WITHOUT ISSUE.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 13798432

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR