BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFREEZE

    MDR report key: 4890717 · Received July 6, 2015

    Report

    Report Number
    3010140265-2015-00005
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 26, 2015
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K150920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, A PHYSICIAN REPORTED SUBCUTANEOUS EMPHYSEMA, SECONDARY TO A PNEUMOTHORAX IN A PATIENT WHO RECEIVED SPRAY CRYOTHERAPY AND BALLOON DILATION FOR A PROXIMAL LEFT MAIN STEM BRONCHUS STRICTURE. FOLLOWING 3 CRYOSPRAYS, BALLOON DILATION WAS USED AND THE STRICTURE OPENED. THERE WAS NO BLEEDING AND NO VISIBLE TEAR OF THE AIRWAY. AFTER THE PATIENT WOKE UP FROM ANESTHESIA, THERE WAS SOME MILD CHEST DISCOMFORT AND FULLNESS AT THE BASE OF THE NECK WITH CREPITUS. SOME DECREASED BREATH SOUNDS ON THE LEFT SIDE WERE NOTED. A CHEST X-RAY CONFIRMED ABOUT A 50% PNEUMOTHORAX. THE PATIENT WAS HEMODYNAMICALLY STABLE, WITH GOOD OXYGENATION, BUT WAS PLACED ON 100% OXYGEN AND CHEST TUBE INSERTED. SHE EXPERIENCED IMMEDIATE SYMPTOMATIC RELIEF. SHE REMAINED HOSPITALIZED OVERNIGHT AND THE PNEUMOTHORAX RESOLVED AND SHE WAS DISCHARGED. ADDITIONAL INFORMATION AND ASSESSMENT: THE PHYSICIAN PROVIDED THE FOLLOWING ADDITIONAL PATIENT/PROCEDURE INFORMATION. THE PATIENT NEVER SMOKED AND HAD HEALTHY LUNGS WITH THE EXCEPTION OF POSSIBLE CHRONIC ACID ASPIRATION FROM A MODERATE HIATAL HERNIA. THE PATIENT HAD A STRICTURE OF THE LEFT MAIN STEM BRONCHUS CLOSE TO THE CARINA. THE STRICTURE WAS FELT TO BE BENIGN AND POSSIBLY DUE TO CHRONIC ASPIRATION. AN ATTEMPT WAS MADE BY ANESTHESIA TO PLACE A 9 MM ETT BUT THAT WAS NOT SUCCESSFUL. AN 8.5 MM ETT WAS SUCCESSFULLY PLACED. THE STRICTURE OCCLUDED APPROXIMATELY 75% OF THE LUMEN AND A BRONCHOSCOPE COULD NOT BE PASSED THROUGH THE STRICTURE WHICH WAS ESTIMATED TO BE 5 MM IN DIAMETER. THE PATIENT WAS FIRST TREATED WITH SPRAY CRYOTHERAPY WITH 4 X 5 SECOND SPRAYS. THE PATIENT WAS PASSIVELY VENTED WITH NO ABNORMALITIES OBSERVED. THE PATIENT UNDERWENT CRE BALLOON DILATION WITH 8, 9, AND 10 MM INCREMENTS. INSPECTION AFTER THE CRE SHOWED A SMALL AMOUNT OF BLOOD AT THE STRICTURE AND A NOTABLE REDUCTION IN THE STRICTURE. ADDITIONAL BALLOON DILATION WAS PERFORMED TO 12 MM. THE BALLOON WAS KEPT INFLATED FOR 90 SECONDS WITH EACH 1MM INCREMENTAL DILATATION. THERE WAS NO BLEEDING OR APPARENT TEAR OF THE AIRWAY. THE PATIENT'S BASELINE O2 SATURATION WAS 96 TO 97%, AND DIPPED TO 89% AT THE LOWEST VALUE DURING THE PROCEDURE. AT EXTUBATION, BLOOD WAS NOTED IN THE POSTERIOR PHARYNX. THE BLEEDING WAS FELT POSSIBLY DUE TO TRAUMA WHEN ATTEMPTING TO INTRODUCE THE 9 MM ETT. THE PHYSICIAN FELT THAT THE BALLOON DILATION MAY HAVE CONTRIBUTED TO THE PNEUMOTHORAX, PARTICULARLY AT THE LARGER SIZES OR SECONDARY TO THE TRAUMA OF INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435482 TRUFREEZE UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL CC3-01

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R