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	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported insufficient ice occurred due to the console system.A visual-ice cryoablation system was chosen for a procedure to treat a patient.During preparation prior to the procedure, the physician found that the refrigeration was abnormal and insufficient ice occurred.A different system of a different model was used to complete the procedure successfully after the procedure, a blockage at air/gas connection of the visual-ice cryoablation system was noted.Through troubleshooting steps, the visual-ice cryoablation system gas connection was cleared, and the visual-ice cryoablation system is fully functional.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: (b)(6).H11: no device return product investigation by manufacturer: the console system was not returned to boston scientific corporation for analysis.It was clarified that during an on-site inspection, the boston scientific corporation field service engineer (fse) found that the intake pipe of the console was blocked and required cleaning to resolve the issue.The console operated normally after it was cleaned.The ifu recommends cleaning the icefx console after each use to ensure proper functionality.The reported event was confirmed by the bsc fse.
Event or Problem Description
It was reported insufficient ice occurred due to the console system.A visual-ice cryoablation system was chosen for a procedure to treat a patient.During preparation prior to the procedure, the physician found that the refrigeration was abnormal and insufficient ice occurred.A different system of a different model was used to complete the procedure successfully after the procedure, a blockage at air/gas connection of the visual-ice cryoablation system was noted.Through troubleshooting steps, the visual-ice cryoablation system gas connection was cleared, and the visual-ice cryoablation system is fully functional.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: 23705617
• Report Number: 2124215-2025-88391
• Device Sequence Number: 16100988
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: (01)00867379000006(11)220803(10)V50069
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: V50069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown