BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 3104783 · Received May 7, 2013

    Report

    Report Number
    3004462490-2013-00011
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    December 10, 2012
    Report Date
    April 12, 2013
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO MALFUNCTION OR ISSUES WITH THE DEVICE WERE REPORTED. THIS ADVERSE EVENT WAS COLLECTED AS PART OF A CLINICAL STUDY. PNEUMOTHORAX IS A KNOWN POTENTIAL ADVERSE EVENT FROM CRYOABLATION PROCEDURES AND IS DOCUMENTED AS SUCH IN THE PRODUCT IFU AND USER MANUAL. THE PT WAS TREATED AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN GALIL'S ECLIPSE LUNG ABLATION STUDY (B)(6) 2012, A PT WAS DIAGNOSED WITH PNEUMOTHORAX, CTCAE GRADE 2, REQUIRING CHEST TUBE < 1 DAY. PT WAS DISCHARGED (B)(6) 2012. EVENT NOTED TO BE RELATED TO THE CRYOABLATION PROCEDURE AND IS A KNOWN POTENTIAL AE RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198433 VISUAL-ICE CRYOABLATION SYSTEM CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL INC. FFRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention