BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOLRAIL LINEAR PEN

    MDR report key: 4172346 · Received October 10, 2014

    Report

    Report Number
    3003502395-2014-00013
    Event Type
    Death
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K073605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETAINED BY THE FACILITY. DEVICE NOT RETURNED FOR EVALUATION HOWEVER DEVICE HISTORY RECORD REVIEWED AND NO NON-CONFORMANCE OR RE-WORK NOTED DURING MANUFACTURING PROCESS THAT WOULD BE RELATED TO THE REPORTED ISSUE. PURSUANT TO THE SURGEON, THE ISSUE WAS BELIEVED TO BE DUE TO PART TO THE NON-TYPICAL PATIENT ANATOMY WHICH MAY HAVE RESULTED IN RF BEING DELIVERED TOO CLOSE TO THE CORONARY ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER VEIN ISOLATION AND TESTING WITH THE EMR2 AND MAX5 THE MCR1 WAS USED TO START ABLATING THE SUPERIOR LEFT ATRIUM. AFTER A FEW 40 SECOND BURNS THE PT'S BLOOD PRESSURE STARTED TO DROP WITH SUBSEQUENT MORPHOLOGY CHANGES IN THE ECG. THEREAFTER THE TEE WAS PERFORMED TO VERIFY ACTIVITY CHANGES IN THE LEFT VENTRICLE AND THE DECISION WAS MADE TO PERFORM A MEDIAN STERNOTOMY. AFTER OPENING THE PATIENT IT WAS OBSERVED THAT THE MCR1 HAD EXTENDED ACROSS AND ABLATED THE LEFT CORONARY ARTERY (CIRCUMFLEX). THE PATIENT EXPIRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642573 COOLRAIL LINEAR PEN SURGICAL DEVICE, ABLATION CARDIAC TISSUE OCL ATRICURE, INC. MCR1 40983

    Patients

    Seq Age Sex Outcome Treatment
    1 Death