BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYO-SPRAY ABLATION SYSTEM

    MDR report key: 3266370 · Received August 1, 2013

    Report

    Report Number
    3004534508-2013-00002
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    July 2, 2013
    Report Date
    August 1, 2013
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K072651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ON SITE EVALUATION: CSA MEDICAL SVC PERSONNEL WAS SENT TO THE SITE ON (B)(4) 2013 (POST EVENT), TO PERFORM FIELD VERIFICATION TESTING PER WORK INSTRUCTION (WI). THE CONSOLE ITSELF (CC2-NAM) PASSED ALL TESTS, AND WAS FOUND TO BE WITHIN SPECIFICATION. TESTING INITIALLY SHOWED THAT THE MEASURED VACUUM SOURCE USING A CSA MEDICAL RECOMMENDED PUMP WAS BELOW SPECIFICATION. IT SHOULD BE NOTED THAT THE VACUUM SOURCE (SUCTION PUMP AND HOSE) WAS TESTED SEPARATE FROM THE CONSOLE, PER WI. SVC FOUND THAT THOSE BETWEEN CONSOLE AND SUCTION PUMP CONSISTED OF 2 SECTIONS INAPPROPRIATELY CONNECTED TOGETHER WITH A SMALL DIAMETER COUPLING. SVC REMOVED THE COUPLING AND ONE HOSE SECTION AND RETESTED THE VACUUM WITH THE MAIN HOSE SECTION IN PLACE. RESULTS EXCEEDED MINIMUM SPECIFICATION. THE FIELD VERIFICATION TESTING WAS THEN COMPLETED AND ALL TESTS PASSED. THE SITE WAS INFORMED OF TEST RESULTS. NOTE: A RELATIONSHIP BETWEEN REDUCED SUCTION AT THE TIME OF FIELD TESTING AND THE ADVERSE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING CRYOTHERAPY OF A SITE IN THE DISTAL 3RD OF THE STOMACH, PT'S ABDOMEN BECAME DISTENDED. TREATMENT WAS STOPPED. SUBSEQUENTLY, PT DEVELOPED ABDOMINAL PAIN. X-RAY SHOWED PNEUMOPERITONEUM. PT WAS HOSPITALIZED, TREATED WITH BOWEL REST AND ANTIBIOTICS, AND WAS DOING WELL WITHOUT SURGERY. DOCTOR PERFORMED PARACENTESIS 2X TO RELEASE ACCUMULATED INTRA ABDOMINAL GAS. PT WAS RELEASED FROM HOSP ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359920 CRYO-SPRAY ABLATION SYSTEM CRYOSPRAY GEH CSA MEDICAL CC2-NAM

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R