BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN¿ COACCESS¿

    MDR report key: 2497470 · Received March 20, 2012

    Report

    Report Number
    3005099803-2012-01003
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED ISSUE OF DIFFICULTY OPENING TINES. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE WAS PERFORMED; NO VISIBLE DAMAGE TO THE DEVICE OR INSULATION WAS FOUND. A FUNCTIONAL EVALUATION WAS PERFORMED, AND FOUND THAT THE ARRAY COULD BE EXTENDED AND RETRACTED AS INTENDED. AS THERE WERE NO VISIBLE OR FUNCTIONAL ISSUES FOUND WITH THE DEVICE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED, WHICH CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS NEEDLE ELECTRODE WAS USED DURING A LIVER RADIOFREQUENCY ABLATION PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A CANCER MASS THAT WAS VERY HARD. DURING THE PROCEDURE, WHEN THE DEVICE WAS INSIDE THE MASS, THE TINES ONLY OPENED APPROXIMATELY FIFTY PERCENT. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT, AND WAS ABLE TO DEPLOY/OPEN THE TINES TWICE. REPORTEDLY, THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE AND THE TINES OPENED UP FINE. THERE WAS NO DAMAGE TO THE DEVICE, OR PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMALLER PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS NEEDLE ELECTRODE WAS USED DURING A LIVER RADIOFREQUENCY ABLATION PROCEDURE PERFORMED ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A CANCER MASS THAT WAS VERY HARD. DURING THE PROCEDURE, WHEN THE DEVICE WAS INSIDE THE MASS, THE TINES ONLY OPENED APPROXIMATELY FIFTY PERCENT. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT, AND WAS ABLE TO DEPLOY/OPEN THE TINES TWICE. REPORTEDLY, THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE AND THE TINES OPENED UP FINE. THERE WAS NO DAMAGE TO THE DEVICE, OR PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMALLER PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN¿ COACCESS¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262240 14953352

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR