BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM

    MDR report key: 6558576 · Received May 10, 2017

    Report

    Report Number
    3011706110-2017-00045
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 13, 2017
    Report Date
    April 13, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K113475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0369.B. THE MAGNET HOUSING ON THE SWIVEL POSITIONER HAD FAILED ALLOWING THE MAGNET TO BECOME DISLODGED FROM THE HOUSING. THE MAGNET WAS NOT RETURNED WITH THE DEVICE. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    DURING TREATMENT OF ATRIAL FIBRILLATION WITH THE FUSION 150 AND A CONCOMITANT LAA OCCLUSION, THE SWIVEL POSITIONER MAGNETIC CAP FROM THE FUSION 150 HAD LOST THE MAGNET. THE MAGNET HAD REMAINED ATTACHED TO THE DISTAL END OF THE FUSION WITHOUT ANY PROBLEM FOR THE PATIENT. THE POSITIONER WAS REPLACED WITH NO DELAY IN CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340307 COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM OCL ATRICURE, INC. 001-700-001MI 66131

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR