BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFREEZE

    MDR report key: 4848759 · Received June 16, 2015

    Report

    Report Number
    3010140265-2015-00004
    Event Type
    Injury
    Date Received
    June 16, 2015
    Date of Event
    May 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K143625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVIDENCE OF MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6) WOMAN WITH STAGE IV METASTATIC LUNG CANCER (BRONCHOGENIC CARCINOMA). SHE HAS A LARGE RIGHT SIDED TUMOR THAT INVOLVES THE RIGHT MAINSTEM BRONCHUS, BRONCHUS INTERMEDIUS AND RIGHT HILUM. THE ENDOBRONCHIAL PORTION OF THE TUMOR IS DESCRIBED AS FUNGATING. METASTASES WERE PRESENT IN THE BRAIN. ON (B)(6) 2015, THE PATIENT UNDERWENT HER SECOND SPRAY CRYOTHERAPY PROCEDURE, WHICH WAS CARRIED OUT USING FLEXIBLE BRONCHOSCOPY THROUGH AN ENDOTRACHEAL TUBE. THE CRYOTHERAPY WAS DIRECTED AT THE RIGHT MAINSTEM AND BRONCHUS INTERMEDIUS USING VARIOUS DURATION PRE-SPRAYS AND THE TYPICAL TARGETED 5 SECOND TIMED SPRAYS. VENTING WAS ACCOMPLISHED BY DISCONNECTING THE VENTILATOR TUBE AND DEFLATING THE CUFF. ANESTHESIA NOTED BRADYCARDIA AND HYPOTENSION DURING THE PROCEDURE. A CHEST X-RAY WAS TAKEN BUT BEFORE IT WAS ABLE TO BE READ, BILATERAL CHEST TUBES WERE PLACED. THE CHEST X-RAY REVEALED A PNEUMOTHORAX BILATERALLY AND PNEUMOMEDIASTINUM. THAT FINDING PROMPTED A TEE WHICH INDICATED THE PRESENCE OF INTRACARDIAC GAS. AT SOME TIME DURING THIS PROCESS, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (CARDIAC ARREST) AND WAS RESUSCITATED, PLACED ON A VENTILATOR, AND TRANSFERRED TO THE ICU. ON TUESDAY (B)(6) 2015 THE PATIENT WAS TRANSFERRED OUT OF THE ICU AND ONTO A WARD. PATIENT IS STILL HOSPITALIZED WITH NEUROLOGICAL DEFICITS AND OFF THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391038 TRUFREEZE UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL CC3-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R| S