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); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient ice occurred.An icefx cryoablation system was selected for a cryoablation procedure of a kidney.The first freeze was completed; however, during the second freeze, the probes did not frost over, and the unit did not sound like it was sending gas through to the probes.The temp displays ranged -100 to -30, but no errors were seen.All the probes were stopped, and the probe that was reading the lowest temperature was unlocked and relocked.This caused an ithaw/cautery malfunction to display.All the probes were started again, and all but one formed frost.A shutdown/restart was performed, and the unit again functioned properly.The procedure was completed with this console.

• 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: 19092814
• Report Number: 2124215-2024-21585
• Device Sequence Number: 7102678
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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: IF0264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown