BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA FUSION 150 MINIMALLY INVASIVE ABLATION

    MDR report key: 5004151 · Received August 12, 2015

    Report

    Report Number
    3003502395-2015-00027
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K113475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT # (B)(4). THE DEVICE WAS RECEIVED AND SENT TO ATRICURE ENGINEERING FOR ANALYSIS. THE COMPLAINT WAS CONFIRMED THE MAGNET WAS DISLODGED FROM THE END OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE POSITIONING THE FUSION PROBE IN THE PATIENT THE MAGNET IN THE INTRODUCER LOCATED IN THE DISTAL END BECAME DETACHED. THIS HAPPENED AFTER THE FIRST SET OF ABLATIONS IT WAS DURING THE SHIFT CHANGE WHEN THE FUSION WAS BEING REPOSITIONED. A SECOND INTRODUCER SET WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT DELAYED THE PROCEDURE FOR 30 MINUTES RETRIEVING MAGNET AND REPOSITIONING THE PROBE. THE PATIENT OUTCOME WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529314 COBRA FUSION 150 MINIMALLY INVASIVE ABLATION COBRA FUSION 150 MINIMALLY INVASIVE ABLATION OCL ATRICURE, INC. 001-700-001MI 14172-052015

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention