BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOSPHERE MAX11

    MDR report key: 22884129 · Received August 25, 2025

    Report

    Report Number
    MW5175189
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    August 19, 2025
    Report Date
    August 20, 2025
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ATRICURE CRYOSPHERE MAX11 USED ON PATIENT AFTER FREEZING IT DID NOT THAW LOT# C10080 OUTDATE; 7/1/2028 REF# A001449.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108213 CRYOSPHERE MAX11 DEVICE, SURGICAL, CRYOGENIC GXH ATRICURE, INC. C10080

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male