BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOLRAIL LINEAR PEN

    MDR report key: 3687388 · Received February 28, 2014

    Report

    Report Number
    3003502395-2014-00001
    Event Type
    Death
    Date Received
    February 28, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 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 PT ANATOMY WHICH MAY HAVE RESULTED IN RF BEING DELIVERED TOO CLOSE TO THE CORONARY ARTERY.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON THE 5TH ABLATION, THE PT BEGAN LOOSING PRESSURE AND WAS CONVERTED TO ON-PUMP. THE SURGEON CONTINUED ABLATION OF THE LEFT PULMONARY VEIN AND GRAFTING. "THE PT WAS TAKEN OFF PUMP AT COMPLETION BUT PRESSURE REMAINED LOW AND A BALLOON WAS THE PT THE PT WAS UNABLE TO BE STABILIZED AND SUBSEQUENTLY EXPIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124292 COOLRAIL LINEAR PEN SURGICAL DEVICE, ABLATION CARDIAC TISSUE OCL ATRICURE, INC. MCR1 48082

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death