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

Model Number	FPRCH7000
Medical Device Problem Codes	Insufficient Cooling (1130); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this unit was generating suboptimal ice.A vi mri cryoablation console was used in a cryoablation procedure.The console did not generate sufficient ice.
Additional Manufacturer Narrative
Device eval by manufacturer: this console was serviced in the field.During inspection, gas was applied to the system and a leak was identified coming from the port area of the msp.The mts board was removed revealing that the o-ring from the gas supply line was blown out from the manifold to desiccant line on port 1.The o-ring was replaced, and functional testing passed with no further issues.A freeze/thaw cycle was completed successfully.
Event or Problem Description
It was reported that this unit was generating suboptimal ice.A vi mri cryoablation console was used in a cryoablation procedure.The console did not generate sufficient ice.
Additional Manufacturer Narrative
Device eval by manufacturer: this console was serviced in the field.During inspection, gas was applied to the system and a leak was identified coming from the port area of the msp.The mts board was removed revealing that the o-ring from the gas supply line was blown out from the manifold to desiccant line on port 1.The o-ring was replaced, and functional testing passed with no further issues.A freeze/thaw cycle was completed successfully.
Event or Problem Description
It was reported that this unit was generating suboptimal ice.A vi mri cryoablation console was used in a cryoablation procedure.The console did not generate sufficient ice.Additional information received indicated that after preventative maintenance was performed in the field that was thought to have resolved the issue, the console was hissing from port 3.Troubleshooting was performed by swapping sockets to another channel and checked socket torque; however, the gas was still leaking on the port 3.Technicians are scheduled to further service this console on 23jan2023.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15880504
• Report Number: 2124215-2022-48574
• Device Sequence Number: 14076742
• Product Code: GEH
• UDI-Device Identifier: 00859019006318
• UDI-Public: 00859019006318
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2023

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: VLM003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 01/04/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/21/2022; 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown