BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 12819837 · Received November 16, 2021

    Report

    Report Number
    2134265-2021-13925
    Event Type
    Death
    Date Received
    November 16, 2021
    Date of Event
    September 30, 2021
    Report Date
    February 3, 2022
    Manufacturer
    BTG ROUND LAKE
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM - NEW INFORMATION ADDED.

    Additional Manufacturer Narrative · 0

    H6 - PATIENT CODES: CHANGED TO EDEMA / SWELLING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. A CRYO CONSOLE AND THREE CRYO NEEDLES WERE SELECTED FOR USE IN A RENAL CRYOABLATION PROCEDURE. THE PATIENTS PREVIOUSLY PLANNED DIALYSIS TREATMENT WAS POSTPONED ONE DAY DUE TO THE PLANNED CRYOABLATION PROCEDURE. THERE WERE NO REPORTED DEVICE ISSUES WITH THE CONSOLE OR TWO OF THE NEEDLES USED. THE THIRD NEEDLE WAS INITIALLY UNABLE TO CREATE AN ICEBALL, BUT AFTER ANOTHER ATTEMPT IT WAS SUCCESSFUL. THERE WERE NO FURTHER REPORTED DIFFICULTIES AND THE PATIENT WAS DISCHARGED. THE NEXT DAY, THE PATIENT WAS FOUND DEAD AT THEIR HOME. THE PATIENT WAS AUTOPSIED AND EXTRA FLUID WAS FOUND IN THE BODY. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS SURE THAT THE PATIENT DEATH WAS NOT CAUSED BY THE CRYO TREATMENT, BUT RATHER BY THE STATE OF THE HEALTH OF THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. A CRYO CONSOLE AND THREE CRYO NEEDLES WERE SELECTED FOR USE IN A RENAL CRYOABLATION PROCEDURE. THE PATIENTS PREVIOUSLY PLANNED DIALYSIS TREATMENT WAS POSTPONED ONE DAY DUE TO THE PLANNED CRYOABLATION PROCEDURE. THERE WERE NO REPORTED DEVICE ISSUES WITH THE CONSOLE OR TWO OF THE NEEDLES USED. THE THIRD NEEDLE WAS INITIALLY UNABLE TO CREATE AN ICEBALL DURING THE NEEDLE TEST PHASE, BUT AFTER ANOTHER ATTEMPT IT WAS SUCCESSFUL. . THERE WERE NO FURTHER REPORTED DIFFICULTIES AND THE PATIENT WAS DISCHARGED. THE NEXT DAY, THE PATIENT WAS FOUND DEAD AT THEIR HOME. THE PATIENT WAS AUTOPSIED AND EXTRA FLUID WAS FOUND IN THE BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. A CRYO CONSOLE AND THREE CRYO NEEDLES WERE SELECTED FOR USE IN A RENAL CRYOABLATION PROCEDURE. THE PATIENTS PREVIOUSLY PLANNED DIALYSIS TREATMENT WAS POSTPONED ONE DAY DUE TO THE PLANNED CRYOABLATION PROCEDURE. THERE WERE NO REPORTED DEVICE ISSUES WITH THE CONSOLE OR TWO OF THE NEEDLES USED. THE THIRD NEEDLE WAS INITIALLY UNABLE TO CREATE AN ICEBALL, BUT AFTER ANOTHER ATTEMPT IT WAS SUCCESSFUL. THERE WERE NO FURTHER REPORTED DIFFICULTIES AND THE PATIENT WAS DISCHARGED. THE NEXT DAY, THE PATIENT WAS FOUND DEAD AT THEIR HOME. THE PATIENT WAS AUTOPSIED AND EXTRA FLUID WAS FOUND IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718274 VISUAL-ICE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH BTG ROUND LAKE FPRCH6000 VL0145 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death