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	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Pro code (product code) - ocl.
Event or Problem Description
It was reported that insufficient ice occurred.A cryo console and an icerod 90 degree mri needle were selected for treatment of a kidney injury of 25x21.During the first freeze at 10 minutes, an iceball of 44x17 was noticed.The physician expected to see an iceball of 45x26.The procedure was completed with this device.During the magnetic resonance imaging (mri) exam, four months after the procedure, the iceball size was deemed not sufficient in covering the targeted tissue.There were no patient complications reported and the patient's status was stable.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14780721
• Report Number: 2134265-2022-06808
• Device Sequence Number: 20096323
• Product Code: GEH
• UDI-Device Identifier: 00859019006318
• UDI-Public: 00859019006318
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

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: Health Professional
• Device Model Number: FPRCH7000
• Device Catalogue Number: FPRCH7000
• Device Lot Number: MRI41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/22/2022
• 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