BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN? SUPERSLIM?

    MDR report key: 3487927 · Received November 25, 2013

    Report

    Report Number
    3005099803-2013-14324
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    October 31, 2013
    Report Date
    November 1, 2013
    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

    REPORTED EVENT: TINES TWISTED/TANGLED. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE ARRAY TO BE FULLY RETRACTED AND NO ISSUES WERE NOTED TO THE CANNULA. A FUNCTIONAL EVALUATION OF THE DEVICE FOUND THE ARRAY TO EXTEND AND RETRACT WITHOUT ANY ISSUES. HOWEVER, THE TINES WERE FOUND TO BE UNEVENLY SPACED AND SLIGHTLY BENT. THE COMPLAINT WAS CONFIRMED. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 ON (B)(6) 2013 THAT A LEVEEN SUPERSLIM ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE ELECTRODE WAS ABLE TO PERFORM THE FIRST ABLATION WITHOUT ANY ISSUES. BEFORE THE SECOND ABLATION, THE ELECTRODE WAS EXAMINED AND WHEN THE TINES WERE EXTENDED THEY SEEMED TO BE TWISTED AND TANGLED WITH ONE ANOTHER. THE TINES WERE RETRACTED AND EXTENDED AGAIN AND THE TINES WERE BACK TO NORMAL AND THEY WERE REPORTED TO BE EVENLY SPACED. THE ELECTRODE PERFORMED ITS SECOND ABLATION AND FINISHED THE PROCEDURE WITHOUT ANY ISSUES. 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 ON NOVEMBER 1, 2013 THAT A LEVEEN SUPERSLIM ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE ELECTRODE WAS ABLE TO PERFORM THE FIRST ABLATION WITHOUT ANY ISSUES. BEFORE THE SECOND ABLATION, THE ELECTRODE WAS EXAMINED AND WHEN THE TINES WERE EXTENDED THEY SEEMED TO BE TWISTED AND TANGLED WITH ONE ANOTHER. THE TINES WERE RETRACTED AND EXTENDED AGAIN AND THE TINES WERE BACK TO NORMAL AND THEY WERE REPORTED TO BE EVENLY SPACED. THE ELECTRODE PERFORMED ITS SECOND ABLATION AND FINISHED THE PROCEDURE WITHOUT ANY ISSUES. 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
    611879 LEVEEN? SUPERSLIM? ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262260 16376505

    Patients

    Seq Age Sex Outcome Treatment
    1