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

Model Number	FPRCH6000
Medical Device Problem Codes	Insufficient Cooling (1130); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
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.During the freezing phase, however, several needles thawed, and the thermosensors detected a rise in temperature despite having sufficient argon.The case was able to be completed, though it is believed that the iceball was affected.Transrectal ultrasound was used to check it visually, but when a needle was active, the ice could not be seen.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H8: usage of device corrected from initial use to reuse.Device evaluation by manufacturer: visual-ice vl0345 was returned to boston scientific for analysis.The returned system was analyzed.Checked the preventative maintenance (pm) status, the next pm was due in less than 6 months.The system was near the end of its pm cycle.Reviewed the log files, there were no errors related to this complaint.Performed the system functional test, all testing passed.Expanded test from testing one channel to a test of all channels.Five channels were tested at a time, 1-5 and 6-10 using ice seed needles.This test was solely a judgement of ice ball size and if there was or was not variation in this size over time.Photos of the ice balls were taken at approximately 2-minute intervals.The first test of channels 1-5 appeared to have some variation in the size of the ice balls.The second test of channels 6-10 looked good.The test of channels 1-5 was repeated.Channels 1-5 then looked like channels 6-10.This change could be attributed to the first test cleaning out the needles (ten minutes of full gas flow) and improving needle performance in the subsequent tests.Testing did not confirm the reported complaint of needles thawing during the freezing process.
Event or Problem Description
It was reported that insufficient ice occurred.A visual-ice cryoablation system was selected for a cryoablation procedure.During the freezing phase, however, several needles thawed, and the thermosensors detected a rise in temperature despite having sufficient argon.The case was able to be completed, though it is believed that the iceball was affected.Transrectal ultrasound was used to check it visually, but when a needle was active, the ice could not be seen.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; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21929045
• Report Number: 2124215-2025-26538
• Device Sequence Number: 9022288
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: (01)00867379000006(11)180201(10)VL0345
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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
• Device Lot Number: VL0345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown