BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN¿ SUPERSLIM¿

    MDR report key: 2638901 · Received July 3, 2012

    Report

    Report Number
    3005099803-2012-02398
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Date of Event
    June 11, 2012
    Report Date
    June 11, 2012
    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

    (B)(4):THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE ARRAY RETRACTED, AND THE CANNULA TIP APPEARED SHARP AND PROPERLY FORMED. THE TINE ARRAY EXTENDED AND RETRACTED WITHOUT ISSUE DURING FUNCTIONAL TESTING. THE TINES WERE NOTED TO BE EVENLY SPACED AND UNDEFORMED. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE TINES WERE DULL; THE COMPLAINT WAS NOT CONFIRMED. THE RETURNED DEVICE SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUE NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN SUPERSLIM ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE TINES WOULD NOT EXTEND INTO THE PATIENT'S LIVER; IT WAS REPORTED THAT THEY SEEMED TOO DULL. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN SUPERSLIM ELECTRODE. THE COMPLAINT DEVICE WAS INSPECTED FOLLOWING REMOVAL FROM THE PATIENT, AND NO VISIBLE ISSUES WERE NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN SUPERSLIM ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, THE TINES WOULD NOT EXTEND INTO THE PATIENT'S LIVER; IT WAS REPORTED THAT THEY SEEMED TOO DULL. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN SUPERSLIM ELECTRODE. THE COMPLAINT DEVICE WAS INSPECTED FOLLOWING REMOVAL FROM THE PATIENT, AND NO VISIBLE ISSUES WERE NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN¿ SUPERSLIM¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262260 14938089

    Patients

    Seq Age Sex Outcome Treatment
    1