BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN? COACCESS?

    MDR report key: 3350561 · Received September 16, 2013

    Report

    Report Number
    3005099803-2013-10910
    Event Type
    Malfunction
    Date Received
    September 16, 2013
    Date of Event
    August 27, 2013
    Report Date
    August 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT: ELECTRODE TINES BENT. 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

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE ARRAY TO BE FULLY RETRACTED AND NO VISIBLE ISSUES WERE NOTED TO THE CANNULA. A FUNCTIONAL EVALUATION FOUND THE ARRAY TO EXTEND AND RETRACT WITHOUT ISSUE; HOWEVER THE TINES WERE FOUND TO BE UN-EVENLY SPACED AND SLIGHTLY BENT. THE COMPLAINT WAS CONFIRMED. THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE OR PORTION OF THE DEVICE WITHOUT DIRECT PATIENT CONTACT EITHER DURING UNPACKING, PREPARATION, OR SHIPPING. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. 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)(4) 2013 THAT A LEVEEN COACCESS ELECTRODE WAS OPENED DURING A RENAL RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, THE TINES WERE NOTED TO BE CROSSED OVER EACH OTHER, AND WERE UNEVENLY SPACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A LEVEEN COACCESS ELECTRODE WAS OPENED DURING A RENAL RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, THE TINES WERE NOTED TO BE CROSSED OVER EACH OTHER, AND WERE UNEVENLY SPACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464174 LEVEEN? COACCESS? ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262240 16055795

    Patients

    Seq Age Sex Outcome Treatment
    1