BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1624625 · Received March 4, 2010

    Report

    Report Number
    3004534508-2010-00001
    Event Type
    Death
    Date Received
    March 4, 2010
    Date of Event
    February 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    CSA MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT: THE TREATING PHYSICIAN CHOSE TO USE THE DEVICE FOR AN APPLICATIONS OUTSIDE THE SCOPE OF THE INTENDED USE, CHOSE NOT TO USE THE TIMING FUNCTION AND THE UNDERLYING CONDITION OF THE PT AT THE TIME OF TREATMENT MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR. A CSA MEDICAL PERSONNEL EVALUATED THE CONSOLE AND FOUND IT TO BE OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PT WAS CRITICALLY ILL SECONDARY TO METASTATIC LUNG DISEASE AND CORONARY ARTERY DISEASE. BRONCHOSCOPIC EXAMINATION REVEALED A TUMOR LOCATED IN THE DISTAL PORTION OF THE MAIN STEM BRONCHI WITH ENDOLUMINAL OBSTRUCTION. PHYSICIAN USED CRYOSPRAY ABLATION TO DESTROY UNWANTED TISSUE AND IMPROVE THE OPENING OF THE AIRWAYS. IMMEDIATELY FOLLOWING THE SPRAY TREATMENT, THE PT DEVELOPED BRADYCARDIA AND TENSION PNEUMOTHORAX. BILATERAL CHEST TUBES WHERE INSERTED TO REMOVE AIR/GAS. IMPROVEMENT NOTED IN PT'S HEMODYNAMIC STATE; HOWEVER, PT DEVELOPED BRADYCARDIA AND STOPPED BREATHING. DESPITE RESUSCITATION EFFORTS, THE PT EXPIRED. THE EXACT CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOSPRAY ABLATION SYSTEM CRYOSPRAY GEH CSA MEDICAL INC. CC2-NAM

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death