BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 2572395 · Received May 8, 2012

    Report

    Report Number
    3004534508-2012-00002
    Event Type
    Injury
    Date Received
    May 8, 2012
    Date of Event
    April 3, 2012
    Report Date
    May 8, 2012
    Manufacturer
    CSA MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN USED THE DEVICE WITHOUT THE CSA CDT/ACTIVE SUCTION AND OUTSIDE OF THE CLEARED LABELING AND INSTRUCTIONS FOR USE. RETRAINING OF THE TREATING PHYSICIAN AND NURSING STAFF WAS COMPLETED BY CSA MEDICAL ON (B)(6) 2012, WITH AN EMPHASIS ON PROPER VENTING TECHNIQUES AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    PT PRESENTED TO (B)(6) FOR CRYOSPRAY TREATMENT OF ESOPHAGEAL CANCER ON (B)(6) 2012. A KNOWN STRICTURE PREVENTED THE CSA SUPPLIED 20 FRENCH, DUAL LUMEN, CSA CRYOGEN DECOMPRESSION TUBE (FOR VENTING) FROM BEING PLACED IN THE PT AS SPECIFIED IN THE INSTRUCTIONS FOR USE. NO ACTIVE VENTING TUBE WAS USED FOR GAS EVACUATION. THE PT'S ABDOMEN WAS MONITORED FOR DISTENTION DURING THE PROCEDURE PER THE INSTRUCTIONS FOR USE (IFU). AFTER A FEW SECONDS INTO THE FIRST SPRAY, THE ABDOMINAL MONITORING NURSE NOTED GASTRIC DISTENTION. THE PT'S ESOPHAGUS AND ABDOMEN WERE EXAMINED ENDOSCOPICALLY AND A LARGE PERFORATION WAS OBSERVED IN THE POSTERIOR WALL OF THE STOMACH. PERFORATION WAS REPAIRED SURGICALLY AND THE PT WAS DISCHARGED 6 DAYS AFTER THE EVENT.

    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 58 YR Hospitalization| L| R