MAUDE Adverse Event Report: BTG ROUND LAKE ICEFX CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH8000
Medical Device Problem Codes	Insufficient Cooling (1130); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was insufficient ice.An icefx cryoablation system was selected for lung tumor cryoablation with two icerod cx 90 degree needles.The needles passed pre-procedure testing prior to use.During the procedure, the physician noted that the ice ball formed on the needles was not shaped as usual.The ice formation was noted to be suboptimal.The procedure was completed with this device.There were no patient complications reported.Troubleshooting performed by the field representative on the icefx console with a demo icerod needle showed the needle passed pre-procedure testing, but the temperature never dropped below -90 celsius (expected to drop to -140 celsius).The system was flushed with low pressure argon gas for ten minutes, however, that did not resolve the reported issue.

• Brand Name: ICEFX CRYOABLATION SYSTEM
• 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: 14290932
• Report Number: 2134265-2022-05165
• Device Sequence Number: 5283349
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: 00859019006370
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K181153
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: FPRCH8000
• Device Catalogue Number: FPRCH8000
• Device Lot Number: IF0140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown