BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 10551168 · Received September 17, 2020

    Report

    Report Number
    2134265-2020-12841
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 18, 2020
    Report Date
    December 21, 2020
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE VISUAL-ICE SYSTEM WAS RETURNED TO THE DISTRIBUTOR FOR TECHNICAL ANALYSIS AND THE ARGON AND HELIUM SOLENOIDS WERE FOUND FAULTY. THE DISTRIBUTOR FIELD SERVICE ENGINEER REPORTED THAT THEY DO NOT INTEND TO ORDER THE REPLACEMENT PARTS UNTIL JANUARY 2021. THE SYSTEM WILL REMAIN OUT OF SERVICE AT THEIR FACILITY UNTIL SUCH TIME THAT THE FAULTY SOLENOIDS CAN BE REPLACED AND THE SYSTEM RESTORED TO PROPER WORKING ORDER. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE ROOT CAUSE OF THE REPORTED INSUFFICIENT ICE WAS TRACED TO A COMPONENT FAILURE. H3 OTHER TEXT : DEVICE EVALUATED BY THIRD PARTY DISTRIBUTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RENAL CRYOABLATION PROCEDURE THE SYSTEM FAILED TO REACH THE DESIRED FREEZING TEMPERATURE. THE ISSUE COULD NOT BE RESOLVED, THEREFORE THE ICE FORMATION WAS SMALLER THAN EXPECTED. THE TREATMENT WAS COMPLETED AFTER FOUR FREEZE CYCLES WITH NO INJURY TO THE PATIENT; HOWEVER, THE INTENDED ABLATION ZONE WAS NOT REACHED. IN THE PHYSICIAN'S OPINION THE TREATMENT WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RENAL CRYOABLATION PROCEDURE THE DESIRED FREEZING TEMPERATURE WAS NOT REACHED. THE ISSUE COULD NOT BE RESOLVED, THEREFORE THE ICE FORMATION WAS SMALLER THAN EXPECTED. THE TREATMENT WAS COMPLETED AFTER FOUR FREEZE CYCLES WITH NO INJURY TO THE PATIENT; HOWEVER, THE INTENDED ABLATION ZONE WAS NOT REACHED. IN THE PHYSICIAN'S OPINION THE TREATMENT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015192 VISUAL-ICE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 VL0170 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1