BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLRAIL LINEAR PEN

    MDR report key: 11894889 · Received May 27, 2021

    Report

    Report Number
    3011706110-2021-00029
    Event Type
    Injury
    Date Received
    May 27, 2021
    Report Date
    May 27, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K190587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER FOR THE MCR1 DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED.

    Description of Event or Problem · 1

    DURING A LITERATURE SEARCH, ATRICURE DETERMINED THAT A PATIENT TREATED BETWEEN 2010 AND 2013 HAD AN ADVERSE EVENT, WHICH MAY HAVE BEEN CAUSED BY OR CONTRIBUTED TO BY THE MCR1 DEVICE. THE LITERATURE REPORTED A PULMONARY VEIN TO ESOPHAGEAL FISTULA FORMED AS A RESULT OF THE SUBSEQUENT CATHETER ABLATION. SURGICAL INTERVENTION WAS NECESSARY AND THE PATIENT FULLY RECOVERED. ATRICURE REVIEWED OTHER COMPLICATIONS LISTED WITHIN THE PAPER, BUT WERE UNABLE TO FIND A CAUSE OR CONTRIBUTION TO AN ATRICURE DEVICE. THIS ADVERSE EVENT IS THE RESULT OF A PROCEDURAL COMPLICATION. NO DEVICE MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793728 COOLRAIL LINEAR PEN COOLRAIL LINEAR PEN OCL ATRICURE, INC. MCR1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R