MAUDE Adverse Event Report: BTG ROUND LAKE ICEFX CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH8000
Medical Device Problem Codes	Insufficient Cooling (1130); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported insufficient ice occurred.An icefx cryoablation system was chosen to complete a left renal cryoablation.The system was turned on and one iceforce 2.1 cx 90 degree needle tested without any errors.The physician inserted the iceforce 2.1 cx 90 degree needle into a satisfactory position and began the freeze cycle.Another non-physician healthcare provider noted there was an absence of ice formation on the iceforce 2.1 cx 90 degree needle, but no error messages occurred.At the end of the first freeze cycle, during the passive thaw cycle, the "80-30" error message displayed and the icefx cryoablation system was unable to freeze as expected.Troubleshooting steps were taken, such as the iceforce 2.1 cx 90 degree needle was changed to another channel on the icefx cryoablation system; however, this did not resolve the issue.The gas was turned off and the icefx cryoablation system was vented.Then, the gas was turned back on, and the error persisted.The physician decided to proceed with the second freeze, and imaging showed an iceball forming that was of expected size for the iceforce 2.1 cx 90 degree needle.Passive thaw was used to complete the procedure.No patient complications were reported.The procedure was completed successfully using the original system.After the procedure, the system was powered down and restarted to troubleshoot and the error message was cleared.

• Brand Name: ICEFX CRYOABLATION SYSTEM
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG ROUND LAKE; 4364 round lake road; arden hills MN 55112
• Manufacturer (Section G): GALIL MEDICAL; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21454126
• Report Number: 2124215-2025-10903
• Device Sequence Number: 7319967
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: 00859019006370
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FPRCH8000
• Device Catalogue Number: FPRCH8000
• Device Lot Number: IF0083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 03/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ICEFORCE 2.1 CX 90 DEGREE NEEDLE UPN FPRPR3602
• Patient Sex: Unknown