BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN? COACCESS?

    MDR report key: 3133569 · Received May 29, 2013

    Report

    Report Number
    3005099803-2013-03998
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: ARRAY DIFFICULT TO EXTEND. 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 NO ISSUES. DURING FUNCTIONAL ANALYSIS THE ARRAY WAS EASILY ABLE TO BE DEPLOYED AND RETRACTED. 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)(4) 2013 THAT A LEVEEN COACCESS ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE IN THE LUNG PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ELECTRODE TO THE TARGET SITE IN THE LUNG; HOWEVER, WHEN HE ATTEMPTED TO OPEN THE DEVICE, THE TINES WOULD NOT ¿CLICK¿ AND STAY OPEN. ANOTHER LEVEEN COACCESS ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT A LEVEEN COACCESS ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE IN THE LUNG PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ELECTRODE TO THE TARGET SITE IN THE LUNG; HOWEVER, WHEN HE ATTEMPTED TO OPEN THE DEVICE, THE TINES WOULD NOT ¿CLICK¿ AND STAY OPEN. ANOTHER LEVEEN COACCESS ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235696 LEVEEN? COACCESS? ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262240 15487783

    Patients

    Seq Age Sex Outcome Treatment
    1