BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 10218949 · Received July 1, 2020

    Report

    Report Number
    2134265-2020-08774
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    May 27, 2020
    Report Date
    September 16, 2020
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY A FIELD SERVICE ENGINEER. TESTING OF THE SYSTEM FOUND FAULTS IN THE DESSICANT LINES OF THE CRYOABLATION SYSTEM, IDENTIFYING THE ROOT CAUSE AS THE FAILURE OF THE DESICCANT TUBE COMPONENT AND CONFIRMING THE REPORTED COMPLAINT. ALL DESSICANT LINES WERE REPLACED, AND FURTHER TESTING OF THE SYSTEM DID NOT IDENTIFY ANY FURTHER ISSUES. A DEVICE HISTORY RECORD DID NOT IDENTIFY ANY RELATED DEVIATIONS FOR THIS CRYOABLATION SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRYOABLATION SYSTEM WITH FOUR CRYOABLATION NEEDLES PRODUCED ICE AT A RATE SLOWER THAN EXPECTED DURING A RENAL CRYOABLATION PROCEDURE, WITH INCONSISTENCIES OBSERVED IN ICEBALL SIZE AND THAW TIME AMONGST THE NEEDLES DURING DIFFERENT CYCLES OF THE CRYOABLATION PROCEDURE. TWO ICEROD CRYOABLATION NEEDLES WERE USED IN CHANNEL 1 AND 2, AND TWO ICESPHERE CRYOABLATION NEEDLES WERE USED IN CHANNEL 3 AND 4. DURING THE FIRST FREEZE CYCLE, THE ICEROD NEEDLES PRODUCED ICE SLOWER THAN THE ICESPHERE NEEDLES, WITH THE SIZE OF THE ICEROD ICEBALL A QUARTER OF THE SIZE EXPECTED DURING THE HALFWAY POINT OF THE PROCEDURE. DURING THE SECOND FREEZE CYCLE, THE ICESPHERE NEEDLES PRODUCED ICE SLOWER THAN THE ICEROD NEEDLES. IN BOTH CYCLES, THE EXPECTED ICEBALL SIZE WAS EVENTUALLY REACHED. THE ACTIVE THAW (ITHAW) MECHANISM WAS NOT FUNCTIONAL FOR ALL OF THE ICESPHERE'S, BUT THE ICEBALL DID EVENTUALLY THAW ENOUGH FOR SAFE REMOVAL OF THE NEEDLES AT THE END OF THE PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRYOABLATION SYSTEM WITH FOUR CRYOABLATION NEEDLES PRODUCED ICE AT A RATE SLOWER THAN EXPECTED DURING A RENAL CRYOABLATION PROCEDURE, WITH INCONSISTENCIES OBSERVED IN ICEBALL SIZE AND THAW TIME AMONGST THE NEEDLES DURING DIFFERENT CYCLES OF THE CRYOABLATION PROCEDURE. TWO ICEROD CRYOABLATION NEEDLES WERE USED IN CHANNEL 1 AND 2, AND TWO ICESPHERE CRYOABLATION NEEDLES WERE USED IN CHANNEL 3 AND 4. DURING THE FIRST FREEZE CYCLE, THE ICEROD NEEDLES PRODUCED ICE SLOWER THAN THE ICESPHERE NEEDLES, WITH THE SIZE OF THE ICEROD ICEBALL A QUARTER OF THE SIZE EXPECTED DURING THE HALFWAY POINT OF THE PROCEDURE. DURING THE SECOND FREEZE CYCLE, THE ICESPHERE NEEDLES PRODUCED ICE SLOWER THAN THE ICEROD NEEDLES. IN BOTH CYCLES, THE EXPECTED ICEBALL SIZE WAS EVENTUALLY REACHED. THE ACTIVE THAW (ITHAW) MECHANISM WAS NOT FUNCTIONAL FOR ALL OF THE ICESPHERE'S, BUT THE ICEBALL DID EVENTUALLY THAW ENOUGH FOR SAFE REMOVAL OF THE NEEDLES AT THE END OF THE PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682383 VISUAL-ICE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 VL0253 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1