MAUDE Adverse Event Report: GALIL MEDICAL INC. ICEFX CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH8000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Procedure date used.
Event or Problem Description
It was reported that a patient was undertreated after cryoablation with a visual-ice system.A patient underwent cryoablation for renal cell carcinoma on (b)(6) 2020.One iceforce cryoablation needle was used.No reported issues occurred during the procedure and the iceball size was confirmed to adequately cover the lesion.During follow up (date unknown), it was identified that the lesion was undertreated, as a result, the patient underwent an additional cryoablation procedure.It was further reported that the most recent post-procedure scan still shows residual tumor.The physician reported that the system is not creating sufficient ice.
Additional Manufacturer Narrative
B3: date of event is unknown.Procedure date used.H3 device eval by manufacturer: system received for service.Testing of the system before performing product maintenance couldn't duplicate the problem.Performed a freeze on all four channels, one needle in each channel.Water used for the bath was cold.Ice ball formation looked normal for each channel.Repeated the test using warm water, temperature about 98 degrees f.Ice balls again looked normal for each channel.Did not measure the ice balls.Performed product maintenance.Adjusted interface manifold alignment to reduce force needed to lock the channels, especially channel 3 and 4.Added missing accessories, dual tank adapter, user manual, ethernet cable, flash drive.
Event or Problem Description
It was reported that a patient was undertreated after cryoablation with a visual-ice system.A patient underwent cryoablation for renal cell carcinoma on (b)(6) 2020.One iceforce cryoablation needle was used.No reported issues occurred during the procedure and the iceball size was confirmed to adequately cover the lesion.During follow up (date unknown), it was identified that the lesion was undertreated and the patient underwent additional cryoablation for re-treatment.It was further reported that the most recent post-procedure scan still shows residual tumor.The physician reported that the system is not creating sufficient ice.

• Brand Name: ICEFX CRYOABLATION SYSTEM
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL INC.; 4364 round lake road; arden hills MN 55112
• MDR Report Key: 10476260
• Report Number: 2134265-2020-12096
• Device Sequence Number: 2880310
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: 00859019006370
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FPRCH8000
• Device Catalogue Number: FPRCH8000
• Device Lot Number: IF0084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention