MAUDE Adverse Event Report: BTG ROUND LAKE VI MRI CRYOABLATION CONSOLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH7000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a massive iceball was created faster than expected and the procedure had to be cancelled.This vi mri cryoablation console was selected for mri cryoablation of a desmoid tumor.During the procedure, all sixteen needles were tested and passed; however, the stick function on the console was not working.They physician opted to turned the 10% freeze option on to get a similar stick effect, but upon scanning the patient they observed a massive size ice ball (8cm in 10 minutes).This is not normal and appears the machine was not producing the correct ice amount.The thaw function was quickly turned on to prevent ice from growing more and the procedure was cancelled (post-sedation).The patient was monitored close and there have been no patient complications or additional treatment reported.
Additional Manufacturer Narrative
Device eval by manufacturer: two solenoid manifolds from visual-ice mri console s/n (b)(6) were returned for analysis.The solenoid manifolds were analyzed.The argon solenoids were disassembled and inspected.The sealing rings on the pins looked normal and the orifices at the bottom of the solenoid ports were open and clean.This inspection was performed without magnification other than a 10x loupe and magnification of photos.There was some black residue on the sides of the pins, which is not uncommon.Measured the argon solenoid coil resistances, they all measured in a range of 59.8 to 61.2 ohms.The solenoid upn label indicated an orifice size of 0.025 inches.Needle port orifices were found to be small.The solenoid needles were found extruding causing reduced flow when the solenoids were energized in the open position.Operating all 8 channels with two needles each would require more gas flow for stick function to operate, as this puts the system at maximum capacity.The stick function not working was an indication of not enough gas flow to generate the ice needed for sticking the needles.Analysis was able to confirm the allegation from the field.
Event or Problem Description
It was reported that a massive iceball was created faster than expected and the procedure had to be cancelled.This vi mri cryoablation console was selected for mri cryoablation of a desmoid tumor.During the procedure, all sixteen needles were tested and passed; however, the stick function on the console was not working.They physician opted to turned the 10% freeze option on to get a similar stick effect, but upon scanning the patient they observed a massive size ice ball (8cm in 10 minutes).This is not normal and appears the machine was not producing the correct ice amount.The thaw function was quickly turned on to prevent ice from growing more and the procedure was cancelled (post-sedation).The patient was monitored close and there have been no patient complications or additional treatment reported.

• Brand Name: VI MRI CRYOABLATION CONSOLE
• 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: 19933415
• Report Number: 2124215-2024-48965
• Device Sequence Number: 19544760
• Product Code: GEH
• UDI-Device Identifier: 00859019006318
• UDI-Public: 00859019006318
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173037
• 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): 08/09/2025

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: FPRCH7000
• Device Catalogue Number: FPRCH7000
• Device Lot Number: VLM007
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRYOABLATION NEEDLES.; CRYOABLATION NEEDLES.
• Patient Sex: Female