MAUDE Adverse Event Report: BTG ROUND LAKE VISUAL-ICE CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH6000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the 53rd annual meeting of the japanese society of interventional radiology, the session chair reviewed case reports of pulmonary embolism with the use of cryoablation.Case review of retrospective study from (b)(6) 2022 to (b)(6) 2023, 71 patients (50 males, 21 females, aged 23-88, average 66 years) with 77 tumors who underwent cryoablation for renal cancer at our hospital were included in this study.Pulmonary thromboembolism was observed on contrast-enhanced ct in 10.4% (8/77) of the cases 1-3 days after cryoablation therapy, all of which were asymptomatic.Six cases were treated with oral edoxaban, one case with oral aspirin, and one case was monitored without medication.Follow-up contrast-enhanced ct at one month showed that the thrombus had disappeared in seven cases, but the case treated with aspirin could not be evaluated as the chest was outside the imaging range.May 25, 2024 (saturday) 13:20 - 14:15 venue 6 general presentation of renal cryotherapy chair: haruyuki takagi, department of radiology, hyogo medical university, takao hiraki, radiology, okayama university graduate school of medicine, dentistry and pharmaceutical sciences.Abstract p268, o-167.Retrospective study on the incidence of pulmonary thromboembolism after cryoablation for renal cancer.Koji tomita1, yusuke matsui2, mayu uga1, noriyuki umakoshi1, takahiro kawabata1, toshihiro ikuchi3, takao hiraki2, 1 department of radiology, okayama university hospital, 2 radiology, okayama university graduate school of medicine, dentistry and pharmaceutical sciences, 3 okayama university graduate school of health sciences.
Additional Manufacturer Narrative
E1.(b)(6).

• Brand Name: VISUAL-ICE 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: 19578074
• Report Number: 2124215-2024-37310
• Device Sequence Number: 3943902
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: 00867379000006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: FPRCH6000
• Device Catalogue Number: FPRCH6000
• Device Lot Number: VL0431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2024
• Initial Report FDA Received Date: 06/20/2024
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown