BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM

    MDR report key: 6527827 · Received April 27, 2017

    Report

    Report Number
    3011706110-2017-00043
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Date of Event
    March 30, 2017
    Report Date
    March 30, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K113475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RECEIVED BY ATRICURE. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO ATRICURE AND PURSUANT TO QRF-0369.B AND WAS VISUALLY AND FUNCTIONALLY TESTED. 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 A OFF-PUMP CARDIAC ABLATION PROCEDURE, THE MAGNET FROM THE FUSION MAGNET RETRIEVER GOT LOOSE AT THE END OF THE PROCEDURE. THE CASE WAS COMPLETED WITHOUT ANY DELAY AND PATIENT OUTCOME WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308266 COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM OCL ATRICURE, INC. 001-700-001MI 66132

    Patients

    Seq Age Sex Outcome Treatment
    1