BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFREEZE SYSTEM

    MDR report key: 5649773 · Received May 12, 2016

    Report

    Report Number
    5649773
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    February 29, 2016
    Report Date
    March 10, 2016
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT INVOLVES AN ELDERLY WOMAN WITH A HISTORY OF PULMONARY (B)(6) COMPLICATED BY STENOSIS OF THE RIGHT BRONCHUS INTERMEDIUS, BREAST CANCER, AND GASTRIC CANCER. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR BRONCHOSCOPY TO TREAT HER BRONCHIAL STENOSIS. FOLLOWING INTUBATION, A FLEXIBLE BRONCHOSCOPY REVEALED A SEVERE CONCENTRIC STENOSIS OF THE RIGHT BRONCHUS. THE ENDOTRACHEAL TUBE (ETT) WAS THEN REMOVED, AND A RIGID BRONCHOSCOPE WAS INTRODUCED TO ALLOW FOR THE PASSAGE OF A THERAPEUTIC BRONCHOSCOPE AND A CATHETER TO ADMINISTER TRUFREEZE CRYOSPRAY, AN FDA-CLEARED LIQUID NITROGEN THERAPY FOR CENTRAL AIRWAY OBSTRUCTION, TO PREVENT OR DECREASE THE EXTENT OF RESTENOSIS. AFTER THE CRYOSPRAY CATHETER WAS PLACED IN THE CORRECT POSITION, A 5-SECOND SPRAY WITH LIQUID NITROGEN WAS ADMINISTERED. THE PATIENT APPEARED TO TOLERATE THIS SPRAY WELL SO A SECOND 5 SECOND SPRAY OF LIQUID NITROGEN WAS DELIVERED. THE PATIENT TOLERATED BOTH SPRAYS WITHOUT DESATURATION. AFTER ADEQUATE VENTILATION, A THIRD LIQUID NITROGEN SPRAY WAS THEN PERFORMED ON THE SAME AREA WITH THE BRONCHOSCOPE IN THE SAME POSITION CONSISTENT WITH THE PARAMETERS FOR ACCEPTED USE. DURING THE THIRD 5-SECOND SPRAY, THE PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA IN HER RIGHT ANTERIOR CHEST. THE PROCEDURE WAS IMMEDIATELY STOPPED. AT THIS TIME, THE PATIENT WAS NOTED TO DEVELOP ST SEGMENT ELEVATIONS IN EKG LEADS II, III, AND AVF WHICH RESOLVED AFTER SEVERAL MINUTES. THE PATIENT'S BLOOD PRESSURE DROPPED REQUIRING AN INCREASE IN PHENYLEPHRINE. AN ETT WAS PLACED. A STAT CHEST X-RAY CONFIRMED BILATERAL PNEUMOTHORACES, PNEUMOPERITONEUM, AND PNEUMOMEDIASTINUM. BILATERAL 12 FRENCH CHEST TUBES WERE INSERTED AND FOLLOW-UP CHEST X-RAY SHOWED IMPROVED EXPANSION BILATERALLY. WHEN THE UPPER AIRWAY WAS EVALUATED, IT WAS CONFIRMED TO BE ADEQUATELY PATENT SO THE PATIENT WAS EXTUBATED AND BROUGHT TO THE ICU FOR CLOSE MONITORING. SOON AFTER THE PATIENT ARRIVED IN THE ICU, THE PATIENT WAS NOTED TO HAVE LEFT UPPER EXTREMITY FLEXION, LEFT LOWER EXTREMITY WEAKNESS, AND LEFT HEMI-NEGLECT. A STROKE CONSULT WAS IMMEDIATELY REQUESTED. THE PATIENT UNDERWENT STAT HEAD CT AND MRI. THESE INITIAL STUDIES WERE INITIALLY UNREMARKABLE, BUT REPEAT MRI DEMONSTRATED NEW SMALL ACUTE INFARCTS IN THE RIGHT MCA DISTRIBUTION. THE STROKE WAS FELT TO BE MOST LIKELY THE RESULT OF GAS EMBOLI RELATED TO THE PROCEDURE. THE PATIENT AND FAMILY WERE INFORMED. THE PATIENT'S NEUROLOGICAL STATUS IMPROVED OVER THE NEXT SEVERAL DAYS WITH INCREASE IN LEFT ARM AND LEG STRENGTH, NORMAL SPEECH AND SWALLOWING FUNCTION. THE PATIENT WAS TRANSFERRED TO INPATIENT REHABILITATION SEVEN DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306014 TRUFREEZE SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R| S NO