BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 5110958 · Received September 29, 2015

    Report

    Report Number
    3004462490-2015-00019
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    August 29, 2015
    Report Date
    September 1, 2015
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE SYSTEM NOR THE NEEDLES WERE RETURNED FOR ANALYSIS. NO INVESTIGATION OF THE NEEDLES OR SYSTEM IS REQUIRED AS THE REPORTED ISSUE DOES NOT IMPLY ANY FAILURES OR MALFUNCTIONS OF GALIL MEDICAL'S PRODUCTS. THIS EVENT REPRESENTS A KNOWN INHERENT RISK OF A LUNG CRYOABLATION AND IS IDENTIFIED IN THE LABELING AS A POTENTIAL ADVERSE EVENT.

    Description of Event or Problem · 1

    AS PART OF THE (B)(6) TRIAL, THE SUBJECT UNDERWENT CRYOABLATION OF FIVE TUMORS ON (B)(6) 2015. POST OPERATIVELY, A PNEUMOTHORAX WAS IDENTIFIED AND THE SUBJECT WAS KEPT OVERNIGHT FOR MONITORING. THE SUBJECT REPORTED A FEW EPISODES OF HEMOPTYSIS (SMALL AMOUNT) FOLLOWING HER PROCEDURE. ON (B)(6) 2015, AN X-RAY SHOWED AN INTERVAL APPEARANCE OF SUBCUTANEOUS EMPHYSEMA AND THE SUBJECT REPORTED RIGHT NECK DISCOMFORT WITH MINIMAL CREPITUS AND SWELLING AND CHEST SWELLING. DISCHARGE WAS CANCELLED AND THE SUBJECT REMAINED HOSPITALIZED OBTAINING SUPPORTIVE CARE AND SUPPLEMENTAL OXYGEN. ON (B)(6) 2015, THE SUBJECT HAD AN INCREASE IN RIGHT SIDED PNEUMOTHORAX, SUBCUTANEOUS EMPHYSEMA AND NONSPECIFIC AIRSPACE DISEASE INVOLVING THE RIGHT LOWER LUNG ASSOCIATED RIGHT SIDED PLEURAL EFFUSION AND A CHEST TUBE WAS PLACED. ON (B)(6) 2015 SUBJECT HAD MILD OOZE COMING FROM THE RIGHT LOWER LOBE AND UNDERWENT FLEXIBLE BRONCHOSCOPY. ON (B)(6) 2015, THE SUBJECT COMPLAINED OF SHORTNESS OF BREATH AND OXYGEN GIVEN VIA VENTI-MASK AND A CT CHEST ANGIOGRAM WAS DONE. AS OF (B)(6) 2015, THE PATIENT DID HAVE AN EPISODE OF HYPOXIA (IN THE 80'S ON 4L) ON (B)(6) 2015 WITH NO GOOD EXPLANATION AS HER CTA CHEST WAS NEGATIVE FOR PE AND HER PNEUMOTHORAX WAS MINIMAL; CHEST TUBE REMOVED ON THE (B)(6) AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642634 VISUAL ICE CRYOABLATION SYSTEM CRYOABLATION DEVICE AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R