BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN¿ STANDARD

    MDR report key: 2221795 · Received August 24, 2011

    Report

    Report Number
    3005099803-2011-02908
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE PRESENCE OF RESIDUE WHICH IS INDICATIVE OF PROCEDURAL USE. ADDITIONALLY, THE ELECTRODE INSULATION WAS FOUND TO BE INTACT. FUNCTIONALLY, THE ARRAY WAS ABLE TO BE FULLY EXTENDED AND RETRACTED. WHEN EXTENDED, THE TINES WERE FOUND TO BE TWISTED AROUND ONE ANOTHER.THE COMPLAINT WAS NOT ABLE TO BE VERIFIED DUE TO THE CONDITION OF THE RETURNED INCIDENT DEVICE. HOWEVER, THE REPORTED EVENT OF DIFFICULTY EXTENDING LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.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. 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).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02907 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO LEVEEN ELECTRODES WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, EACH ARRAY WAS ABLE TO BE EXTENDED INTO THE LESION, BUT THE PHYSICIAN FELT THAT BOTH FAILED TO FULLY EXTEND TO THE 4CM DIAMETER. ADDITIONALLY, A SINGLE ABLATION TREATMENT WAS ADMINISTERED WITH EACH ELECTRODE FOLLOWING THE APPROPRIATE ALGORITHM, BUT ROLL-OFF WAS ACHIEVED WITHIN 2 MINUTES USING BOTH DEVICES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. REPORTEDLY, NO VISIBLE ISSUES WERE PRESENT WITH EITHER DEVICE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02907 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO LEVEEN ELECTRODES WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, EACH ARRAY WAS ABLE TO BE EXTENDED INTO THE LESION, BUT THE PHYSICIAN FELT THAT BOTH FAILED TO FULLY EXTEND TO THE 4CM DIAMETER. ADDITIONALLY, A SINGLE ABLATION TREATMENT WAS ADMINISTERED WITH EACH ELECTRODE FOLLOWING THE APPROPRIATE ALGORITHM, BUT ROLL-OFF WAS ACHIEVED WITHIN 2 MINUTES USING BOTH DEVICES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. REPORTEDLY, NO VISIBLE ISSUES WERE PRESENT WITH EITHER DEVICE. 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¿ STANDARD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262130 0014255475

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR