BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1273509 · Received December 22, 2008

    Report

    Report Number
    3004534508-2008-00011
    Event Type
    Death
    Date Received
    December 22, 2008
    Date of Event
    November 24, 2008
    Report Date
    December 22, 2008
    Manufacturer
    CSA MEDICAL INC
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTENDING PHYSICIAN DISCONNECTED THE VENTILATOR PRIOR TO THE FIRST CRYOSPRAY TREATMENT. AFTER RECONNECTING THE VENTILATOR, THE PEAK PRESSURE WENT UP, SUGGESTING SOME TYPE OF INTRATHORACIC MALFUNCTION. NONETHELESS, THE PHYSICIAN CONTINUED WITH A SECOND CRYOSPRAY TREATMENT. AFTER RECONNECTING THE VENTILATOR AFTER THE SECOND TREATMENT, THE PEAK PRESSURES WENT UP AGAIN, SUGGESTING CONTINUED INTRATHORACIC MALFUNCTION. THE PATIENT THEN DEVELOPED BRADYCARDIA. AN X-RAY REVEALED BILATERAL PNEUMOTHORACIES. BILATERAL CHEST TUBES WERE INSERTED WITH BRIEF IMPROVEMENT IN GAS EXCHANGE BEFORE PT ULTIMATELY PASSED AWAY. CSA MEDICAL PERSONNEL EVALUATED THE CONSOLE AND FOUND IT TO BE OPERATING WITHIN SPECIFICATIONS. A MEDICAL ADVISOR TO CSA MEDICAL REVIEWED THIS SITUATION WITH THE ATTENDING PHYSICIAN. THE PHYSICIAN INFORMED CSA MEDICAL THAT HE UNDERTOOK THIS TREATMENT AS AN EXTREME LIFE SUSTAINING MEASURE. THE OPINION OF THE MEDICAL ADVISOR IS THAT THERE WERE MULTIPLE FACTORS CONTRIBUTING TO THIS EVENT, INCLUDING BUT NOT LIMITED TO THE PT'S ADVANCED AGE, EXTENSIVE AMOUNTS OF NECROTIC DEBRIS AND TISSUE IN THE AIRWAYS, ADVANCED STAGE OF LUNG CANCER, RESPIRATORY FAILURE, CRYOSPRAY THERAPY, AND HIGH BASELINE VENTILATOR PRESSURES.

    Description of Event or Problem · 1

    PT WAS CRITICALLY ILL SECONDARY TO ADVANCED LUNG CANCER AND RESPIRATORY FAILURE. PT WAS ALSO ON A MECHANICAL VENTILATOR DUE TO THEIR TERMINAL ILLNESS AND RESPIRATORY FAILURE. BRONCHOSCOPIC EXAMINATION REVEALED EXTENSIVE AMOUNTS OF NECROTIC DEBRIS AND TISSUE IN THE AIRWAYS WITH ENDOLUMINAL OBSTRUCTION. PHYSICIAN USED SPRAY CRYOTHERAPY TO IMPROVE OPENING OF THE AIRWAYS. FOLLOWING TREATMENT AND RE-VENTILATION, THE PT DEVELOPED BRADYCARDIA AND BILATERAL PNEUMOTHORACIES. DESPITE AGGRESSIVE RESUSCITATION EFFORTS, THE PT EXPIRED. 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 70 YR Death