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

Model Number	FPRCH8000
Medical Device Problem Codes	Defective Device (2588); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an inability to deactivate thawing function occurred.An icefx cryoablation system was selected for use.The first freeze cycle was activated and passive heating performed with no problems across all ports.A second freeze cycle was performed with no problems.During the final heating phase, there were no problems with passive thaw; however, when actively initiating the heating, two ports failed simultaneously.Once i-thaw was started on the rest of the needles, thawing could not be stopped.The pause-stop button was blocked.The physician quickly initiated the freeze option on all needles and stop them again right away.Passive thaw was used and the needles were removed.There were no patient complications reported.

• 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: 14212129
• Report Number: 2134265-2022-04573
• Device Sequence Number: 4383423
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: 00859019006370
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/26/2022

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: FPRCH8000
• Device Catalogue Number: FPRCH8000
• Device Lot Number: ICP0225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown