BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3CM GUIDED COAG DEVICE GEN 4

    MDR report key: 6094753 · Received November 10, 2016

    Report

    Report Number
    3003502395-2016-00157
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    July 28, 2016
    Report Date
    November 2, 2016
    Manufacturer
    ATRICURE INC.
    Product Code
    OCL
    PMA / PMN Number
    K120857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NUMBER (B)(4). THE DEVICE WAS NOT RETURNED TO ATRICURE FOR EVALUATION AS THERE WAS NO INDICATION OF A DEVICE DEFECT OR MALFUNCTION. NO KNOWN MALFUNCTION, FACILITY DISCARED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT ONE PATIENT HAD RETURNED AFTER A CONVERGENT PROCEDURE WITH A PERICARDIAL EFFUSION. THE EFFUSION WAS DRAINED. THE PATIENT IS IN SINUS RHYTHM. PER ADDITIONAL INFORMATION THAT WAS RECEIVED ON 11/02/2016, PATIENT IS NOW PRESENTING WITH INCISIONAL HERNIA REQUIRING SURGERY TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742841 3CM GUIDED COAG DEVICE GEN 4 EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX OCL ATRICURE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention CANNULA