BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFREEZE CRYOSPRAY

    MDR report key: 5708425 · Received June 9, 2016

    Report

    Report Number
    3010140265-2016-00004
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    May 13, 2016
    Report Date
    June 7, 2016
    Manufacturer
    CSA MEDICAL, INC
    Product Code
    GEH
    PMA / PMN Number
    K160273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CLAIM OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    PATIENT INJURY OF PNEUMOTHORAX DURING A PROCEDURE. THE DOCTOR WAS USING A RIGID SCOPE, 5 CYCLES OF 10 SECOND SPRAYS ON LOW FLOW IN THE PROXIMAL LMB AND 4 CYCLES OF 5 SECOND SPRAYS ON THE DISTAL TRACHEAL STENT. DR THEN USED A CRYO PROBE ON THE DISTAL LMB, JUST PAST THE STENT, FOLLOWED BY BALLOON DILATION. HE THEN PREPPED FOR ONE MORE SPRAY. HE REQUESTED THE TRUFREEZE BE SWITCHED TO LOW FLOW AS HE DECIDED TO SPRAY THE DISTAL LMB. BEFORE THERE WAS A NOTICEABLE FROST ON THE TREATMENT SITE, THE NURSE ALERTED THAT THERE WAS A RISE IN THE CHEST. THE DOCTOR IMMEDIATELY STOPPED SPRAYING AND PULLED OUT THE SCOPE. HE THEN INVESTIGATED THE LUNGS UNDER FLUOROSCOPY AND SAW A PNEUMOTHORAX ON THE NON-OPERATIVE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365622 TRUFREEZE CRYOSPRAY UNIT, CYOSURGICAL, ACCESSORIES, GEH CSA MEDICAL, INC CC3-01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R