BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 4839726 · Received June 11, 2015

    Report

    Report Number
    3004462490-2015-00013
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    January 7, 2015
    Report Date
    March 11, 2015
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLES WERE NOT RETURNED SO AN INVESTIGATION COULD NOT BE CONDUCTED. HOWEVER, IT IS LIKELY THE GAS FLOW ISSUE WAS DUE TO MOISTURE CONTAMINATION IN THE GAS SUPPLY LINES USED WITH THE VISUAL ICE SYSTEM. GALIL MEDICAL HAS IMPLEMENTED AN AUTOMATIC FLUSH SEQUENCE IN SOFTWARE VERSION 1.2.9 AND HAS MADE SHORTER GAS LINES AVAILABLE TO CUSTOMERS. MOISTURE CAUSING A GAS CLOG IN A NEEDLE IS A KNOWN INHERENT RISK IN ANY CRYOABLATION PROCEDURE. THE VISUAL ICE USER MANUAL PROVIDES TROUBLESHOOTING INSTRUCTIONS ON FLUSHING A NEEDLE IF A CUSTOMER SUSPECTS A GAS CLOG. HEMORRHAGE AND PNEUMOTHORAX ARE KNOWN POTENTIAL ADVERSE EVENTS WITH A CRYOABLATION PROCEDURE AND ARE DOCUMENTED IN THE SYSTEM USER MANUAL.

    Description of Event or Problem · 1

    THIS EVENT IS CONNECTED TO COMPLAINT(B)(4) WHICH WAS PREVIOUSLY CLOSED WITH NO MDR OR OTHER REPORTING. A NEW COMPLAINT IS BEING OPENED ASSOCIATED WITH THE FIRST ONE. THE INITIAL COMPLAINT WAS PROMPTED BY A CRYOABLATION PROCEDURE ON (B)(6) 2015 WHERE THE VISUAL ICE SYSTEM HAD GAS LINE CLOGGING. THIS OCCURRED DURING A CLINICAL TRIAL CASE ASSOCIATED WITH THE SOLSTICE TRIAL. SUBJECT (B)(6) HAD TWO TUMORS TREATED ON (B)(6) 2015. THERE WERE NO ISSUES WITH FIRST TUMOR TREATED (NUMBERED #2) BUT THE SECOND TUMOR (NUMBERED #1) HAD LINE CLOGGING ISSUES. THE PHYSICIAN MODIFIED THE FREEZE/THAW CYCLES AND THE PROCEDURE WAS COMPLETED. AT THE TIME, IT APPEARED THE LINE CLOGGING HAD NO IMPACT ON THE TREATMENT OR AFFECTED THE SUBJECT. NOTE: THERE WAS A REPORT OF HEMORRHAGE ASSOCIATED WITH THIS SUBJECT (TUMOR #1) BUT THERE WAS NO TREATMENT FOR THE HEMORRHAGE AND PER THE STUDY, THIS WAS CONSIDERED AN ANTICIPATED EVENT AND WAS NOT REPORTABLE AS AN ADVERSE EVENT WITHIN THE STUDY. THIS WAS NOT IN THE PHYSICIAN DICTATION BUT THE INFORMATION PROVIDED CAME FROM THE COORDINATOR. ON (B)(6) 2015, GALIL MEDICAL WAS NOTIFIED VIA PHONE BY THE CLINICAL TRIAL COORDINATOR AT (B)(4) THAT SOLSTICE SUBJECT (B)(6) WAS GOING TO NEED A REPEAT CRYOABLATION ON A PREVIOUS ABLATED TUMOR (TUMOR #1). THIS WAS THE TUMOR WHERE GAS LINE CLOGGING OCCURRED ON (B)(6) 2015. THE RE-TREATMENT (REPEAT CRYOABLATION USING GALIL MEDICAL TECHNOLOGY) TO THIS TUMOR TOOK PLACE ON (B)(6) 2015. THERE WAS A REPORTED MINOR INTRAPROCEDURAL PNEUMOTHORAX (NO ASPIRATION OR CHEST TUBE PLACED) AND NO REPORTED SYSTEM/NEEDLE ISSUES OR MALFUNCTION. PER STUDY GUIDELINES, THE PNEUMOTHORAX WAS NOT REPORTED AS AN ADVERSE EVENT AND WAS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382988 VISUAL ICE CRYOABLATION SYSTEM CRYOSURGICAL SYSTEMS AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other