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

Model Number	FPRCH8000
Medical Device Problem Codes	Insufficient Cooling (1130); Insufficient Heating (1287); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient ice occurred.An icefx cryoablation system was reported to have a 40-08 ithaw error in the past.Additionally, the console was not forming large enough ice balls on the needles connected to channels 2a and 2b.Using ct imaging in the most recent case with this console, it was observed that insufficient ice occurred on the needles in channels 2a and 2b after 7 minutes of operating time.The needles were switched to different channels to resolve the issue, and no patient complications were reported.The console is not being used until the issue is resolved.
Event or Problem Description
It was reported that insufficient ice occurred.An icefx cryoablation system was reported to have a 40-08 ithaw error in the past.Additionally, the console was not forming large enough ice balls on the needles connected to channels 2a and 2b.Using ct imaging in the most recent case with this console, it was observed that insufficient ice occurred on the needles in channels 2a and 2b after 7 minutes of operating time.The needles were switched to different channels to resolve the issue, and no patient complications were reported.The console is not being used until the issue is resolved.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the icefx s/n (b)(6) was returned to the complaint investigation site for analysis.System documentation was reviewed including system log files.There were no log files for the reported event date on 30aug2024.There were no recorded ithaw errors.During initial functional testing, the ice balls for all channels looked similar.A gas leakage inspection was performed and it failed.Based on the date of manufacture, the icefx was due for a preventative maintenance.Degraded desiccant is the primary cause of small ice.Low gas pressure is also a contributor to reduced ice formation.No i-thaw errors occurred during testing.Confirmed the complaint of small ice formation on channel two.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20296553
• Report Number: 2124215-2024-59242
• Device Sequence Number: 7200168
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: 00859019006370
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: FPRCH8000
• Device Catalogue Number: FPRCH8000
• Device Lot Number: ICP0425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown