BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1082323 · Received March 7, 2008

    Report

    Report Number
    127116-2008-00001
    Event Type
    Injury
    Date Received
    March 7, 2008
    Date of Event
    February 6, 2008
    Report Date
    March 7, 2008
    Manufacturer
    CSA MEDICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRYOSPRAY ABLATION SYSTEM IS USED TO DESTROY UNWANTED TISSUE VIA THE APPLICATION OF LIQUID NITROGEN. THE PHYSICIAN APPLIED CRYOGEN FOR 20 SECONDS AND THEN STOPPED. AT THIS TIME, THE PT'S ABDOMEN WAS NOTED TO BE FIRM, AND PATIENT'S BLOOD PRESSURE APPEARED TO BE LOW. THE PHYSICIAN ADVANCED THE ENDOSCOPE AND INSUFFLATED WITH AIR. AS THE PHYSICIAN INSUFFLATED, THE PT BECAME DISTENDED. THE PHYSICIAN SUSPECTED A PERFORATION. TREATMENT WAS STOPPED. FURTHER TESTING CONFIRMED A SMALL PERFORATION. THE PHYSICIAN QUALIFIED BY CSA MEDICAL TO USE THE CRYOSPRAY ABLATION SYSTEM WAS OVERSEEING THE TRAINING OF ANOTHER PHYSICIAN, "DR. AND INSTRUCTING HIM ON ITS USE. CSA MEDICAL STAFF WERE PRESENT DURING THE PROCEDURE. CSA MEDICAL STAFF NOTED THAT THE PROCEDURE WAS CONDUCTED PER CSA TRAINING GUIDELINES, AND NOTED THAT ACCESSORIES WERE USED PROPERLY. CSA MEDICAL STAFF ALSO NOTED THAT THE CONSOLE WAS FUNCTIONING PROPERLY AT THE TIME OF THE INCIDENT. CSA MEDICAL CONDUCTED A FOLLOW UP VISIT AND REPEATED THE INSTALLATION VERIFICATION "CH...." THE MANUFACTURING RECORDS FOR THE CONSOLE AND CATHETER KIT ACCESSORY WERE REVIEWED; RESULTS SHOWED THAT FIELD DEVICES WERE TESTED AND APPROVED FOR RELEASE NO PROBLEMS NOTED. SUBSEQUENT PROCEDURES CONDUCTED AT THIS FACILITY HAVE BEEN SUCCESSFUL AND NO PROBLEMS NOTED. CSA MEDICAL CONSULTED A MEDICAL EXPERT WITH SIGNIFICANT EXPERIENCE IN THE USE OF THE CRYOSPRAY ABLATION SYSTEM. THE PHYSICIAN SPECULATED THAT THE POSITIONING OF THE SUCTION/VENT LUMEN IN RELATION TO THE HIATAL HERNIA MAY HAVE RESULTED IN SUBOPTIMAL SUCTION OF ABDOMINAL GAS. IT IS ALSO POSSIBLE THAT THE PROCESS OF INSUFFLATING THE PT AFTER THE PROCEDURE CONTRIBUTED TO THE PERFORATION. AT THIS TIME, THERE IS NOT ENOUGH INFO TO CONCLUSIVELY DETERMINE CAUSE.

    Description of Event or Problem · 1

    DURING A PROCEDURE USING THE CRYOSPRAY ABLATION SYSTEM, THE PATIENT EXPERIENCED A SMALL PERFORATION DISTAL TO THE TREATMENT SITE. THE CONDITION RESOLVED WITHOUT SURGERY. THE PT WAS ADMITTED TO THE HOSP FOR MONITORING. THE PT WAS DISCHARGED IN 2008.

    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 * Hospitalization