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

Model Number	FPRCH6000-02
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported insufficient ice occurred.A visual-ice cryoablation system was chosen to complete a renal tumor cryoablation.The physician and another physician noted the ice formation was less than expected.There were no patient complications as a result of this event.The procedure was completed successfully.The physician believed the treatment was adequate even though the ice formation was less than expected.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc as the account did not have the available information.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.
Event or Problem Description
It was reported insufficient ice occurred.A visual-ice cryoablation system was chosen to complete a renal tumor cryoablation.The physician and another physician noted the ice formation was less than expected.There were no patient complications as a result of this event.The procedure was completed successfully.The physician believed the treatment was adequate even though the ice formation was less than expected.
Additional Manufacturer Narrative
D4: model number, lot number, catalog number, serial number, unique identifier (udi) # updated, product details provided by product investigation team.

• Brand Name: VISUAL-ICE CRYOABLATION SYSTEM US
• 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: 22090573
• Report Number: 2124215-2025-34226
• Device Sequence Number: 17874072
• Product Code: GEH
• UDI-Device Identifier: 00859019006462
• UDI-Public: (01)00859019006462(11)210401(10)NVI0028
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: FPRCH6000-02
• Device Catalogue Number: FPRCH6000-02
• Device Lot Number: NVI0028
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown