BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYO SPRAY ABLATION

    MDR report key: 2400641 · Received January 3, 2012

    Report

    Report Number
    3004534508-2011-00006
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    December 6, 2011
    Report Date
    January 3, 2012
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRYOSPRAY SYSTEM OPERATED NORMALLY AND MET ALL ACCEPTANCE CRITERIA DURING A SUBSEQUENT FIELD VERIFICATION TEST. NO ERRORS OF THE BUILD-IN TEST PERFORMED AT EACH SYSTEM POWER-UP WERE RECORDED. THE PHYSICIAN BELIEVES THE PERFORATION WAS RELATED TO EXPANDING GAS FROM THE CRYOSPRAY PROCEDURE AS A RESULT OF THE SMALLER NG VENT TUBE USED IN PLACE OF THE RECOMMENDED CRYOGEN DECOMPRESSION TUBE SUPPLIED WITH THE CSA DISPOSABLE KIT AND SPECIFIED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    PT PRESENTED FOR CRYOSPRAY TREATMENT OF ESOPHAGEAL CANCER ON (B)(6) 2011. A KNOWN STRICTURE PREVENTED THE CSA SUPPLIED 20 FRENCH DUAL LUMEN CSA CRYOGEN DECOMPRESSION (VENT) FROM BEING PLACED IN THE PT AS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU). INSTEAD, A 14 FRENCH NASOGASTRIC (NG) TUBE WAS INSERTED IN THE PT AND USED FOR EVACUATING THE GAS. THE PT'S ABDOMEN WAS MONITORED FOR DISTENTION DURING THE PROCEDURE PER THE IFU. AFTER 10 SECONDS INTO THE FIRST FREEZE, THE ABDOMINAL MONITORING NURSE NOTED ACUTE DISTENTION. THE PHYSICIAN STOPPED THE CRYOSPRAY, ENSURED SUCTION WAS ON, AND WAITED FOR THE GAS TO DISSIPATE. THE ABDOMEN REMAINED DISTENDED LONGER THAN EXPECTED. THE NG TUBE WAS REMOVED AND THE PT'S ESOPHAGUS AND ABDOMEN WERE EXAMINED ENDOSCOPICALLY. THE PHYSICIAN OBSERVED A PERFORATION IN THE STOMACH. THE PT WAS TAKEN TO SURGERY APPROX 30 MINUTES AFTER THE PERFORATION WAS DISCOVERED. A LAPAROTOMY WAS PERFORMED TO SURGICALLY REPAIR THE PERFORATION. THE PT WAS DISCHARGED FROM THE HOSPITAL APPROXIMATELY 1 WEEK POST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYO SPRAY ABLATION CRYO SPRAY ABLATION GEH CSA MEDICAL CC2-NAM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R