BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 18445242 · Received January 4, 2024

    Report

    Report Number
    2124215-2023-75081
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    December 11, 2023
    Report Date
    February 6, 2024
    Manufacturer
    BTG ROUND LAKE
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): GEH, OCL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE FORMATION. A CRYO CONSOLE WAS SELECTED FOR USE FOR A CRYOABLATION PROCEDURE. DURING TREATMENT, THERE WAS INADEQUATE TREATMENT DUE TO INSUFFICIENT ICE FORMATION DURING THE SECOND FREEZE PERIODS. NO PATIENT INJURIES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE FORMATION. A CRYO CONSOLE WAS SELECTED FOR USE FOR A CRYOABLATION PROCEDURE. DURING TREATMENT, THERE WAS INADEQUATE TREATMENT DUE TO INSUFFICIENT ICE FORMATION DURING THE SECOND FREEZE PERIODS. NO PATIENT INJURIES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE SAME SITUATION OF INSUFFICIENT ICE OCCURRED NOT ONLY ON ONE CHANNEL, BUT ALSO WHEN THE NEEDLE WAS CHANGED TO ANOTHER CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467606 VISUAL-ICE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH BTG ROUND LAKE FPRCH6000 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown