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

Model Number	FPRCH8000
Medical Device Problem Codes	Device Alarm System (1012); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error codes resulted in an unsuccessful ablation.A icefx cryoablation system was selected for use in a renal mass ablation procedure.During the procedure, they were unable to finish the freeze due an error code 80-30 related to internal pressure checks.An additional error code 40-08 was also observed related to automatic stop of electrical thawing on all system channels.These error codes occurred outside of the patient, however resulted in an unsuccessful ablation procedure for this patient.Product maintenance was performed on the device a week after this procedure, where the probes were replaced and the device appears to be working as expected.

• 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: 13043530
• Report Number: 2134265-2021-15754
• Device Sequence Number: 5436663
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: 00859019006370
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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: IF0138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female