BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA FUSION 150 ABLATION SYSTEM

    MDR report key: 7138424 · Received December 21, 2017

    Report

    Report Number
    3011706110-2017-00109
    Event Type
    Injury
    Date Received
    December 21, 2017
    Report Date
    December 21, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K113475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES WERE NOT RETURNED FOR EVALUATION AS THE ADVERSE EVENT OCCURRED POST-PROCEDURE. A PRODUCT HISTORY REVIEW WAS UNABLE TO BE PERFORMED; NO DEVICE SPECIFIC LOT OR SERIAL NUMBERS WERE REPORTED. THERE WAS NO REPORTED DEVICE MALFUNCTION DURING THE INITIAL PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A MALE PATIENT RECEIVED AN OFF-PUMP, TOTALLY THORACOSCOPIC MAZE PROCEDURE WITH LAA MANAGEMENT USING A COBRA FUSION 150 ABLATION SYSTEM. THE PATIENT WAS HEPARINIZED FOR THE PROCEDURE WITH AN ACT MEASURED AT OVER 300 SECONDS. THE HEPARIN WAS NOT REVERSED POST PROCEDURE, AND ORAL ANTICOAGULANTS WERE USED PRIOR TO AND POST PROCEDURE. THE PROCEDURE REPORTEDLY WENT AS EXPECTED WITH BETWEEN 15 AND 20 ABLATIONS PERFORMED ON THE PULMONARY VEINS. WITHIN ONE OR TWO DAYS POST PROCEDURE THE PATIENT REPORTEDLY HAD A STROKE WITH THE RESIDUAL EFFECTS OF LATERAL BLURRY VISION. THE CURRENT PATIENT STATUS IS FINE. THERE WAS NO REPORTED DEVICE MALFUNCTION WITH THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919810 COBRA FUSION 150 ABLATION SYSTEM COBRA FUSION 150 ABLATION SYSTEM OCL ATRICURE, INC. 001-700-001S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S MID1, EMR2, EML2, MLP1, PRO2