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

Model Number	FPRCH6000-02
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system was producing insufficient ice.The visual-ice cryoablation system was selected for a cryoablation procedure to treat a renal tumor.During testing, however, the system was producing insufficient ice.The first probe was tested, and no ice ball was formed in the saline.A second probe of the same lot number was inserted into a different channel and tested, and the same issue of no ice ball formation occurred.A third probe from a different lot was tested and the same issue of no ice ball formation occurred.The system was shut down, the argon gas tanks were disconnected and reconnected, and the seal on the tanks and the machine were checked again.The system was turned back on and the second and third probes were reconnected.When inserting the probes, there was resistance, but they were able to be inserted and tested again.However, no ice ball had formed again.The radiologist noted that the probes felt hot during the last test.The cryoablation system was not used for the procedure, and the procedure was completed using an alternative method.There were no patient complications reported.The defective needles were tested again with the same visual-ice cryoablation system a few days later, and all the devices worked as expected.

• Brand Name: VISUAL-ICE CRYOABLATION SYSTEM US
• 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: 15905690
• Report Number: 2124215-2022-47473
• Device Sequence Number: 17490514
• Product Code: GEH
• UDI-Device Identifier: 00859019006462
• UDI-Public: 00859019006462
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

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: FPRCH6000-02
• Device Catalogue Number: FPRCH6000-02
• Device Lot Number: NVI0017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown