BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 2103537 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01859
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE INSULATION TO BE INTACT AND UNDAMAGED. FUNCTIONALLY, THE ARRAY WAS ABLE TO BE EXTENDED AND RETRACTED WITHOUT ISSUE. WHEN EXTENDED, THE TINES OF THE ARRAY WERE FOUND TO BE TWISTED AND DEFORMED. NO OTHER DEVICE DAMAGE WAS VISIBLE. CONTINUITY OF CURRENT WAS CONFIRMED WITH THE ELECTRODE WHICH IS INDICATIVE OF PROPER CONNECTIVITY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT ARRAY WAS DIFFICULT TO RETRACT. HOWEVER, THE EVALUATION FOUND THAT THE TINES WERE TWISTED AND DAMAGED. DURING MANUFACTURING, ELECTRODES ARE 100% INSPECTED FOR DEVICE INTEGRITY, SO THE DAMAGE 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 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)(4), 2011.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ARRAY WAS DIFFICULT TO RETRACT. THE USER REPORTED THAT THE ARRAY APPEARED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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

    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) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ARRAY WAS DIFFICULT TO RETRACT. THE USER REPORTED THAT THE ARRAY APPEARED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262130 14189752

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR