BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1831248 · Received September 10, 2010

    Report

    Report Number
    3005099803-2010-03822
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 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 EVALUATION FOUND THAT THE INSULATION ON THE CANNULA HAD PEELED 9.9 TO 11.1 CENTIMETERS AND 12.0 TO 12.3 CENTIMETERS DISTAL THE HANDLE. FUNCTIONALLY, THE ARRAY WAS ABLE TO BE EXTENDED AND RETRACTED WITHOUT ISSUE. WHEN EXTENDED, THE ARRAY TINES WERE FOUND TO BE EVENLY SPACED AND UNDEFORMED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE INSULATION PEELED. INFORMATION WAS RECEIVED FROM THE ACCOUNT WHICH CONFIRMED THE USE OF A METAL NEEDLE GUIDE WITH THE ELECTRODE. THE DIRECTIONS FOR USE (DFU) CAUTION THE USER OF POTENTIAL COMPLICATIONS IF A METAL NEEDLE GUIDE IS USED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION. 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

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO ADVANCE THE ELECTRODE THROUGH A METAL NEEDLE GUIDE, THE INSULATION WAS PEELED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LEVEEN NEEDLE ELECTRODE. 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 NEEDLE ELECTRODE WAS USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO ADVANCE THE ELECTRODE THROUGH A METAL NEEDLE GUIDE, THE INSULATION WAS PEELED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LEVEEN NEEDLE ELECTRODE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262280 13339254

    Patients

    Seq Age Sex Outcome Treatment
    1