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

Model Number	FPRCH6000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Movement Disorder (4412)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that iceball grew large enough to surround the nerve.This visual-ice cryoablation system was used with 15 needles to treat a desmoid tumor.During the second freeze cycle, the iceball was getting close to a nerve.The six probes on that margin closest to the nerve were all set to active thaw using helium.After being set to active thaw, constant mri imaging observed that the iceball grew toward the nerve for two additional minutes after being placed into active thaw.The iceball ultimately encompassed the nerve causing the patient discomfort/pain and foot drop syndrome.Further details were requested to obtain any additional intervention provided; however, no further details were available.
Event or Problem Description
It was reported that iceball grew large enough to surround the nerve.This visual-ice cryoablation system was used with 15 needles to treat a desmoid tumor.During the second freeze cycle, the iceball was getting close to a nerve.The six probes on that margin closest to the nerve were all set to active thaw using helium.After being set to active thaw, constant mri imaging observed that the iceball grew toward the nerve for two additional minutes after being placed into active thaw.The iceball ultimately encompassed the nerve causing the patient discomfort/pain and foot drop syndrome.Further details were requested to obtain any additional intervention provided; however, no further details were available.Additional information reported the desmoid tumor was located on the proximal calf and no error messages were observed on the console during the procedure.

• 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): BTG ROUND LAKE
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20923943
• Report Number: 2124215-2024-78449
• Device Sequence Number: 8314466
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: 00867379000006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown