BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN ELECTRODE

    MDR report key: 1952437 · Received January 7, 2011

    Report

    Report Number
    3005099803-2011-00003
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 26, 2010
    Report Date
    December 17, 2010
    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

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION:THE ARRAY WAS ABLE TO BE FULLY RETRACTED PRIOR TO WITHDRAWAL FROM THE PATIENT. FURTHERMORE, THE ACCOUNT WAS ABLE TO CONFIRM THAT THERE WAS NO ALLEGED MALFUNCTION AGAINST THE REPLACEMENT COACCESS INTRODUCER SET.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00053 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM AND A COACCESS INTRODUCER SET WERE USED DURING A LUNG RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER PERFORMING SEVERAL COMPOUND BURNS IN THE PATIENT'S LUNG TUMOR, THE ARRAY'S TINES BECAME MISSHAPEN. THE CONSULTANT TRIED A NEW INTRODUCER WITHOUT SUCCESS. IT COULD NOT BE DETERMINED WHAT SPECIFIC INTRODUCER ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. 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
    1 LEVEEN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262240 13727387

    Patients

    Seq Age Sex Outcome Treatment
    1