BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 4939281 · Received July 24, 2015

    Report

    Report Number
    3004462490-2015-00015
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 24, 2015
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICES USED IN THIS PROCEDURE. GAS EMBOLISM IS A KNOWN INHERENT RISK IN A CRYOABLATION PROCEDURE. AIR EMBOLISM IS DOCUMENTED IN THE LITERATURE AS A VERY RARE BUT POTENTIALLY LIFE-THREATENING COMPLICATION FOLLOWING ANY PERCUTANEOUS NEEDLE-BASED PROCEDURE, INCLUDING LUNG BIOPSY AND THERMAL ABLATION (KYUNGMOUK, STEVE LEE ET AL. ALTERNATIVE TO SURGERY IN EARLY STAGE NSCLC - INTERVENTIONAL RADIOLOGIC APPROACHES. TRANSL LUNG CANCER RES. 2013 OCT; 2(5): 340-353. PULMONARY EMBOLISM IS IDENTIFIED IN THE VISUAL ICE SYSTEM USER MANUAL AS A POTENTIAL ADVERSE EVENT. THE EMBOLISM RESOLVED ITSELF IN LESS THAN 5 MINUTES AND THE PATIENT WAS HOSPITALIZED AND MONITORED BUT NO ADDITIONAL TREATMENT WAS REQUIRED. THE PATIENT WAS DISCHARGED TWO DAYS LATER.

    Description of Event or Problem · 1

    ON (B)(6) 2015, RIGHT AFTER CRYOABLATION OF ONE METASTATIC LUNG TUMOR TREATED AS PART OF THE SOLSTICE TRIAL, IT WAS REPORTED THAT THE SUBJECT EXPERIENCED A GASEOUS EMBOLISM (CTCAE GRADE 4). THE SUBJECT UNDERWENT SUBSEQUENT CARDIAC AND NEUROLOGICAL MONITORING. MEDICATION WAS PROVIDED (UNKNOWN TYPE). NO OTHER TREATMENT OR INTERVENTION WAS GIVEN. IT WAS REPORTED THE EVENT RESOLVED ON (B)(6) 2015. THE SUBJECT WAS DISCHARGED ON (B)(6) 2015. A GALIL MEDICAL CRA SPOKE TO THE SITE ABOUT THIS EVENT AND REPORTED THE FOLLOWING INFORMATION:. THE PROCEDURE AND ALL OF THE FREEZING WAS PERFORMED WITHOUT COMPLICATION. WHEN THE TWO CRYO NEEDLES WERE REMOVED, THE ANESTHESIOLOGIST NOTICED AN ABNORMAL RHYTHM ON EKG FOR A FEW MINUTES. THE PHYSICIANS DID ANOTHER CT AND THEY NOTICED A GAS EMBOLISM IN THE LEFT ATRIUM AND THE AORTA. THE EKG CHANGES AND GAS EMBOLISM LASTED LESS THAN 5 MINUTES AND THEN RESOLVED. THE PATIENT WAS EXTUBATED WITHOUT COMPLICATION. THE PATIENT WAS SENT TO ICU OVERNIGHT FOR MONITORING, BUT THERE WERE NO FURTHER OCCURRENCES OF EKG ABNORMALITY AND THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS TRANSFERRED TO A STANDARD ROOM ON SATURDAY (B)(6) 2015, AND DISCHARGED ON MONDAY (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482067 VISUAL ICE CRYOABLATION SYSTEM CRYOSURGICAL DEVICES AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| H