BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE

    MDR report key: 20976748 · Received December 19, 2024

    Report

    Report Number
    1528319-2024-00109
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 16, 2024
    Report Date
    December 19, 2024
    Manufacturer
    CSA MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND LATER THAT SAME DAY, THE PATIENT EXPERIENCED A STROKE. THE USER FACILITY HAS MENTIONED THAT THE PATIENT WAS COMPLAINING OF DISCOMFORT/TINGLING IN THEIR UPPER LEFT EXTREMITY FOLLOWING THE PROCEDURE. THE PATIENT WAS UNDER TREATMENT FOR ESOPHAGEAL CANCER. THE LOG FILES FOR THE TRUFREEZE CONSOLE SYSTEM WERE REVIEWED AND NO ISSUES WERE NOTED. THE TRUFREEZE CONSOLE SYSTEM WAS CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING INFORMATION: "THE PHYSICIAN SHOULD CAREFULLY CONSIDER PATIENT ELIGIBILITY FOR CRYOSPRAY ABLATION (I.E., CRYOSURGERY AND ASSOCIATED GAS PRESSURE), INCLUDING PATIENT PRESENTATION, MEDICAL HISTORY, CO-MORBIDITIES (E.G., COPD, CAD), AND PROLONGED USE OF STEROIDS THAT MAY REDUCE THE PATIENT'S TISSUE COMPLIANCE AND TISSUE STRENGTH AFFECTING THEIR ABILITY TO TOLERATE CRYOSPRAY. ANY THERAPY OR PROCEDURE COMPROMISING THE INTEGRITY OF THE TISSUE, SPECIFICALLY IN OR ADJACENT TO THE TARGETED ABLATION AREA. THE PHYSICIAN SHOULD USE CAUTION WHEN APPLYING CRYOSPRAY IN ANY ORGAN WHERE STRICTURE OR COLLAPSE IS LIKELY. THE PHYSICIAN SHOULD USE CAUTION WHEN CONSIDERING CRYOSPRAY FOR THIS HIGH-RISK PATIENT SITUATION, SPECIFICALLY REGARDING THE ABILITY TO VENT OR EXTRACT GAS. PHYSICIANS SHOULD USE CAUTION IN ANY PROCEDURE OR ANATOMY WHERE A RESTRICTION OR OBSTRUCTION INTERFERES WITH THE ADEQUATE VENTING OR NITROGEN AS, RESULTING IN INCREASED GAS PRESSURE. DURING CRYOSPRAY, THE PATIENT MUST BE MONITORED FOR ABDOMINAL DISTENTION AND CRYOSPRAY MUST BE STOPPED IF THE ABDOMEN BECOMES DISTENDED, IF USING IN THE ESOPHAGUS. LIQUID NITROGEN EXPANDS MORE THAN 700 TIMES WHEN CHANGING FROM A LIQUID TO A GASEOUS STATE. IT IS IMPERATIVE FOR PATIENT SAFETY THAT ADEQUATE VENTING IS USED TO REMOVE GAS CREATED DURING CRYOSPRAY." A STERIS TERRITORY MANAGER OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF TRUFREEZE CONSOLE; HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT FOLLOWING A PROCEDURE INVOLVING USE OF A TRUFREEZE, THE PATIENT EXPERIENCED A STROKE. THE PATIENT IS RECEIVING REHABILITATION SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083064 TRUFREEZE TRUFREEZE CONSOLE GEH CSA MEDICAL, INC. CC3-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown