BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 4956851 · Received July 31, 2015

    Report

    Report Number
    3004462490-2015-00017
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 14, 2015
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS REQUESTED BY THE DISTRIBUTOR IN (B)(4) THE (B)(4) GAS COMPANY CONDUCTED AN INVESTIGATION ON THE HELIUM TANK. THE RESULTS OF THE INVESTIGATION OF THE TANK REVEALED THE WHISTLING SOUND WAS DUE TO AN ISSUE WITHIN THE HELIUM TANK. NO FURTHER INVESTIGATION OF THE GALIL MEDICAL SYSTEM OR NEEDLES IS REQUIRED. GALIL MEDICAL CONFIRMED THAT THE PATIENT UNDERWENT EMBOLIZATION TO STOP THE BLEEDING. FURTHER FOLLOW-UP CONFIRMED THAT AFTER OBSERVATION THE PATIENT'S CONDITION WAS WELL AND THE PATIENT WAS DISCHARGED FROM THE MEDICAL FACILITY THE FOLLOWING DAY.

    Additional Manufacturer Narrative · 1

    GALIL MEDICAL'S DISTRIBUTOR IN (B)(4) IS A TRAINED AUTHORIZED SERVICE PROVIDER. THE DISTRIBUTOR INVESTIGATED THE SYSTEM FOLLOWING THE CASE TO DIAGNOSE THE CAUSE OF THE LOUD WHISTLING SOUND. THE PRESSURE GAUGE WAS CONNECTED TO BOTH ARGON AND HELIUM TANKS. A SINGLE NEEDLE WAS USED TO TEST THE FUNCTIONALITY OF THAWING. NO ABNORMAL SOUND WAS HEARD. THE DISTRIBUTOR HAS REQUESTED (B)(4) TO CONDUCT AN INVESTIGATION ON THAT PARTICULAR HELIUM TANK. GALIL MEDICAL HAS REQUESTED FOLLOW-UP STATUS OF THE PATIENT. BLEEDING IS A WELL KNOWN AND DOCUMENTED COMPLICATION WITH CRYOABLATION PROCEDURES AND IS LISTED IN THE VISUAL ICE SYSTEM USER MANUAL AS A POTENTIAL ADVERSE EVENT. ADDITIONALLY, ICEBALL CRACKING IS A COMMON OCCURRENCE IN CRYOABLATION, AS THE ICE IS TRANSITIONING FROM VERY COLD FREEZING TO WARMING AND THAWING. A FOLLOW-UP MDR WILL BE FILED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE, THE 1ST CYCLE WAS SMOOTHLY DELIVERED. DURING THE 2ND FREEZE-THAW CYCLE, A LOUD "WHISTLING SOUND" RELEASED FROM HELIUM TANK DURING THAWING AND THE INDICATION OF "LOW LEVEL HELIUM GAS" WAS DISPLAYED. AS A RESULT, ACTIVE THAWING WAS ABORTED FOR SAFETY. PASSIVE THAWING FOR 8 MINUTES WAS SUGGESTED TO COMPLETE THE PROCEDURE. DESPITE PASSIVE THAWING, THE PATIENT WAS MOVING DRASTICALLY AND MONITORING PARAMETERS WERE UNSTABLE. AFTER 8 MINUTES OF PASSIVE THAWING, MEDICAL DOCTOR PULLED OUT THE NEEDLES BUT HAD SOME RESTRICTIONS. EVENTUALLY, ALL THREE NEEDLES WERE PULL OUT. POST CT SCAN WAS DONE AND IDENTIFIED THAT PATIENT HAD BLEEDING IN LEFT RENAL AND THE ICE BALL HAD CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499276 VISUAL ICE CRYOABLATION SYSTEM CRYOSURGICAL DEVICE AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other