MAUDE Adverse Event Report: BTG ROUND LAKE VISUAL-ICE CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH6000
Medical Device Problem Codes	Insufficient Cooling (1130); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient ice occurred.A visual ice cryoablation system was selected for a cryoablation procedure to treat a kidney tumor.After testing, the needles were connected to channels 1 and 3.When stick mode was performed, there was a sound of gas leaking from inside the console.The console was restarted, but the leaking sound continued.After changing the needles to channels 5 and 7, the gas leak became smaller.However, the iceball formation was smaller than usual.A third needle was added, and the cryotherapy was continued.It is suspected that the auto vent solenoid valves in the console were not completely closed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter first name and initial reporter last name corrected e1: initial reporter email removed g2: report source (other) added.
Event or Problem Description
It was reported that insufficient ice occurred.A visual ice cryoablation system was selected for a cryoablation procedure to treat a kidney tumor.After testing, the needles were connected to channels 1 and 3.When stick mode was performed, there was a sound of gas leaking from inside the console.The console was restarted, but the leaking sound continued.After changing the needles to channels 5 and 7, the gas leak became smaller.However, the iceball formation was smaller than usual.A third needle was added, and the cryotherapy was continued.It is suspected that the auto vent solenoid valves in the console were not completely closed.There were no patient complications as a result of this event.

• Brand Name: VISUAL-ICE 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, INC.; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21647514
• Report Number: 2124215-2025-15234
• Device Sequence Number: 20758282
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: 00867379000006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: FPRCH6000
• Device Catalogue Number: FPRCH6000
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown