BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICURE CRYOICE CRYOABLATION SYSTEM (CRYO2)

    MDR report key: 17142629 · Received June 16, 2023

    Report

    Report Number
    17142629
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 24, 2023
    Report Date
    May 31, 2023
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    UDI-DI
    30840143902646
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ELDERLY MALE WITH CAD (CORONARY ARTERY DISEASE) AND NEW ONSET OF SOB (SHORTNESS OF BREATH). PROCEDURE: CABG X 2 (CORONARY ARTERY BYPASS GRAFT), MITRAL VALVE REPLACEMENT, MAZE AND LEFT ATRIAL APPENDAGE OCCLUSION. THE PROBE WAS INSIDE THE PATIENT AND DID NOT FREEZE WHEN USED. IT WAS REMOVED FROM THE PATIENT AND ATTEMPTED TO REACTIVATE OUTSIDE THE BODY AND WOULD NOT FREEZE. A NEW ONE OBTAINED AND FROZE WITHOUT ISSUES. NO KNOWN HARM TO PATIENT- DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR DEVICE, SURGICAL, CRYOGENIC, ATRICURE CRYOICE CRYOABLATION SYSTEM (CRYO2) (PER SITE REPORTER): WILL OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494420 ATRICURE CRYOICE CRYOABLATION SYSTEM (CRYO2) DEVICE, SURGICAL, CRYOGENIC GXH ATRICURE, INC. CRYO2 126011 30840143902646

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA Male