BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLRAIL LINEAR PEN

    MDR report key: 11100312 · Received December 31, 2020

    Report

    Report Number
    3011706110-2020-00035
    Event Type
    Injury
    Date Received
    December 31, 2020
    Date of Event
    December 14, 2020
    Report Date
    January 20, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K190587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE MCR1 DEVICE, LOT NUMBER 103090, WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED. THE DEVICE PASSED ALL INSPECTION CRITERIA AND THE FUNCTIONAL CHECK, THERE WAS NOT MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MCR1 DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER 103090. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020 A PATIENT UNDERWENT A THORACOSCOPIC MAZE PROCEDURE. THE PHYSICIAN WAS ABLATING WITH THE MCR1 DEVICE ON THE LEFT SIDE IN-BETWEEN THE LEFT SUPERIOR PULMONARY VEIN AND THE LEFT ATRIAL APPENDAGE AND A PERFORATION OCCURRED THAT RESULTED IN BLEEDING THAT REQUIRED CONVERTING THE PROCEDURE TO AN OPEN STERNOTOMY. THE PATIENT WAS STABILIZED, AND PUT-ON BYPASS TO REPAIR THE AREA OF TISSUE WITH SUTURES. THE LESION SET WAS COMPLETED, AND PATIENT WEANED OFF BYPASS. PATIENT STABILIZED POST-PROCEDURE AND WAS DISCHARGED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564368 COOLRAIL LINEAR PEN COOLRAIL LINEAR PEN OCL ATRICURE, INC. MCR1 103090

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R