BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1931572 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05257
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 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 RETRACTED. FUNCTIONALLY, THE ARRAY WAS ABLE TO BE EXTENDED AND RETRACTED. HOWEVER, RESISTANCE WAS ENCOUNTERED. WHEN EXTENDED, THE ARRAY TINES WERE FOUND TO BE EVEN AND UNDEFORMED. AFTER SEVERAL ACTUATIONS, THE ARRAY WAS NOT ABLE TO BE RETRACTED. THE HANDLE WAS SEPARATED FOR EXAMINATION AND THE CENTER OF THE MALE LUER CAP WAS FOUND TO BE BROKEN. THE CENTER OF THE CAP REMAINED ATTACHED TO THE CANNULA PROXIMAL END. ADDITIONALLY, THE OUTER DIAMETER OF THE CANNULA WAS MEASURED AND WAS FOUND TO MEET SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT RESISTANCE WAS ENCOUNTERED WHEN THE ARRAY WAS ACTUATED. THE EVALUATION WAS ABLE TO DUPLICATE THIS RESISTANCE. HOWEVER, DURING THE ANALYSIS, AFTER SEVERAL ACTUATIONS, THE ARRAY FAILED TO RETRACT. THIS CONDITION WAS ATTRIBUTED TO A SEPARATED MALE LUER CAP. SINCE THIS SECONDARY FAILURE OCCURRED DURING THE EVALUATION, AN ACCURATE ROOT CAUSE CANNOT BE IDENTIFIED FOR THE RESISTANCE. THEREFORE, 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).

    Additional Manufacturer Narrative · 1

    (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, DURING PREPARATION, RESISTANCE WAS ENCOUNTERED WHEN THE ARRAY WAS EXTENDED AND RETRACTED. 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 GOOD.

    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, DURING PREPARATION, RESISTANCE WAS ENCOUNTERED WHEN THE ARRAY WAS EXTENDED AND RETRACTED. 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 GOOD.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THERE WERE NO VISIBLE ISSUES WITH THE LEVEEN COACCESS ELECTRODE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262220 13447912

    Patients

    Seq Age Sex Outcome Treatment
    1