BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICEROD PLUS 1.5 CRYOABLATION SYSTEM

    MDR report key: 4173814 · Received August 11, 2014

    Report

    Report Number
    9616793-2014-00013
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K110946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CT SCAN RENAL CRYOABLATION PROCEDURE IN WHICH THE PHYSICIAN USED 3 ICEROD PLUS NEEDLES AND A VISUAL ICE SYSTEM, TNE NEEDLES DID NOT PERFORM OPTIMALLY. THE ISSUE OCCURRED DURING THE PROCEDURE WHILE THE PT WAS UNDER ANESTHESIA. DURING THE FIRST FREEZE CYCLE, ONE NEEDLE DID NOT FREEZE COMPLETELY AND THERE WAS A LACK OF ICE ON THE HANDLE AND A WEAK ICEBALL WAS SEEN ON CT. THE USER CHANGED CHANNELS WITH THE NEEDLES AND THE NEEDLES BEGAN FORMING MORE ICE, HOWEVER, ONE OF THE OTHER NEEDLES BEING USED STOPPED FORMING ICE. WHILE THE NEEDLES WERE FUNCTIONING, THE ICE BEING FORMED WAS NOT OPTIMAL. THE PROCEDURE WAS COMPLETED AFTER 3 FREEZING CYCLES WITH NO PT INJURY. HOWEVER, THE PHYSICIAN IS UNCERTAIN HOW SUCCESSFUL THE PROCEDURE WAS AND WILL CONTINUE TO FOLLOW UP THE PT PER NORMAL FOLLOW UP PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476129 ICEROD PLUS 1.5 CRYOABLATION SYSTEM CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL LTD. FPRPR3508 B3970-001, B3716-001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK