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

Model Number	FPRCH7000
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was insufficient ice.A visual ice mri cryoablation console was selected for a cryoablation procedure.It was reported that there were issues with getting the right size iceballs.The device seemed to be working at 50% capacity.There were no patient complications reported.
Event or Problem Description
It was reported that there was insufficient ice.A visual ice mri cryoablation console was selected for a cryoablation procedure.It was reported that there were issues with getting the right size iceballs.The device seemed to be working at 50% capacity.There were no patient complications reported.It was further reported that the account was using a 15 meter gas line that was connected to a wall outlet to supply gas for the procedure.During troubleshooting, it was recommended the account connect a full argon cylinder and conduct a 10 minute freeze cycle using an iceseed needle.The account performed the recommended troubleshooting and there were no further clogging or small ice ball size reported.It was determined that there was no problem with the console.The issue was with the account's use of the gas line to connect to the wall outlet instead of an argon gas tank.
Additional Manufacturer Narrative
B5.Updated event description or problem with additional information received from the gsms service record.

• 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: 14466260
• Report Number: 2134265-2022-05751
• Device Sequence Number: 14627554
• Product Code: GEH
• UDI-Device Identifier: 00859019006318
• UDI-Public: 00859019006318
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: Other
• Device Model Number: FPRCH7000
• Device Catalogue Number: FPRCH7000
• Device Lot Number: MRI41
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown