BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 2062813 · Received April 5, 2011

    Report

    Report Number
    3004534508-2011-00001
    Event Type
    Death
    Date Received
    April 5, 2011
    Date of Event
    February 24, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CSA MEDICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE INSTITUTION REGARDING THE DEATH, INCLUDING THE PROCEDURE SUMMARY, AUTOPSY REPORT AND/OR DEATH CERTIFICATE. THE INSTITUTION HAS DECLINED TO PROVIDE ADDITIONAL INFORMATION. TREATING PHYSICIAN INDICATED DEVICE OPERATED NORMALLY. NO ERRORS OF BUILT-IN TEST PERFORMED AT SYSTEM START-UP WERE NOTED. SUBSEQUENT TESTING OF THE DEVICE BY CSA MEDICAL ALSO INDICATED THE DEVICE PERFORMED NORMALLY. PHYSICIAN CHOSE TO USE SYSTEM FOR TREATMENT OUTSIDE THE SCOPE OF THE CLEARED INDICATIONS OF USE (I.E. LUNG). PHYSICIANS INDICATED THEY HAD BEEN INFORMED IT WAS OUTSIDE THE INDICATIONS FOR USE AND HAD BEEN WARNED AGAINST ITS USE IN THE LUNG. THEY BELIEVE THERE IS A CORRELATION BETWEEN CRYOTHERAPY TREATMENT AND THE EVENT. NO INSTRUCTIONS (OR TRAINING) EXIST FOR USE OF THE CSA SYSTEM WITHOUT THE ACTIVE SUCTION SYSTEM (E.G., IN THE LUNG).

    Description of Event or Problem · 1

    PT PRESENTED TO SCHEDULED BRONCHOSCOPIC OUTPATIENT PROCEDURE WITH RECURRENT PNEUMONIA IN LEFT LUNG SECONDARY TO LEFT MAIN STEM OBSTRUCTION FROM ANEURYSM WITH HEMATOMA. CONSCIOUS SEDATION WAS EMPLOYED AND AN ENDOTRACHEAL TUBE (ET) WAS NOT PLACED. PT REC'D FIVE CYCLES OF FIVE SECOND CRYOSPRAY THERAPY AT LEFT MAIN STEM OBSTRUCTION. A BALLOON DILATATION WAS THEN PERFORMED FOR STENOSIS (70%) AT PROXIMAL LEFT MAIN STEM BRONCHUS. PT THEN REC'D ONE CYCLE OF FIVE SECOND CRYOSPRAY THERAPY DISTAL TO THE STENOSED SITE FOR GRANULATION TISSUE DESTRUCTION. PT BECAME BRADYCARDIC, AND SUBSEQUENTLY WENT INTO CARDIAC ARREST. SHE WAS INTUBATED AND FULL ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS RENDERED. SPONTANEOUS CIRCULATION RETURNED AND PT WAS TRANSFERRED TO MEDICAL INTENSIVE CARE UNIT (MICU). PT SUBSEQUENTLY EXPIRED.

    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 57 YR Death