BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 3054511 · Received April 9, 2013

    Report

    Report Number
    3004462490-2013-00001
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. THROMBOSIS 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 RELEASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) HAD A PERCUTANEOUS ABLATION OF A LEFT PULMONARY MODULE AND RIGHT RETROPERITONEAL MASS WAS PERFORMED ON (B)(6) 2013. AFTER PROCEDURE AND DURING HOSPITALIZATION PT'S ARTERIAL VENOUS (AV) FISTULA WAS FOUND TO HAVE THROMBOSED AND WENT FOR THROMBECTOMY ON (B)(6) 2013. PT DID WELL AND WAS DISCHARGED ON (B)(6) 2013. SINCE THIS PT HAD A KNOWN (PRE-EXISTING) AV FISTULA, THIS POTENTIAL ADVERSE EVENT WAS DISCUSSED IN DETAIL WITH THE PT PRIOR TO THE PROCEDURE AND PRECAUTIONS WERE TAKEN TO TRY AND PREVENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144695 VISUAL-ICE CRYOABLATION SYSTEM CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention