BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE

    MDR report key: 11912322 · Received June 1, 2021

    Report

    Report Number
    11912322
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 12, 2021
    Manufacturer
    CSA MEDICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CRYO THERAPY EQUIPMENT WAS SET UP FOR TREATMENT OF PATIENT. UPON FIRST CRYO SPRAY CATHETER SPRAYED WITHOUT ISSUE. WHEN DOCTOR ATTEMPTED TO DO A SECOND PASS WITH CATHETER THE CATHETER FROZE COMPLETELY AND WAS UNABLE TO BE USED FOR THE REMAINDER OF THE CASE. NURSING PULLED A SECOND CATHETER AND DOCTOR ATTEMPTED TO SPRAY THE CATHETER OUT SIDE OF THE PATIENT TO VERIFY USE AND SECOND CATHETER COMPLETELY FROZE AND WAS UNABLE TO BE USED TO FINISH CASE. PATIENT THEREFORE WAS UNABLE TO FINISH HIS TREATMENT AND WILL NEED TO BE RESCHEDULED FOR AN ADDITIONAL TREATMENT BEFORE REEVALUATION OF THIS TREATMENT PLAN CAN BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810828 TRUFREEZE UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL, INC. 20-00184 0507

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA