MAUDE Adverse Event Report: BTG YOKNEAM ICESPHERE 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via literature that a venous thrombosis occurred post-cryoablation treatment, requiring medication.The cryoablation was performed using a visual ice console and two icesphere needles under local anesthesia and computed tomography (ct) fluoroscopy guidance.The two adjacent renal cell carcinomas (rcc) were ablated simultaneously in two freezing cycles (10 and 12 min), with 2 min of passive thawing in between.After each cycle, the operator confirmed that the target was within a low-attenuation area, known as an ice-ball, on ct scan with sufficient circumferential ablation margin.Some of the liver parenchyma was included in the ice-ball, but the procedure was carried out without any immediate complications.On day 2 post-cryoablation, contrast-enhanced ct revealed a thrombus in the portal vein in segment 6 near the ablated liver parenchyma, and oral anticoagulant therapy (edoxaban, 60 mg/day) was initiated.The patient was discharged on day 4 post-cryoablation without any sequelae, and a follow-up contrast-enhanced ct performed 6 weeks later revealed the resolution of the portal vein thrombus.
Additional Manufacturer Narrative
B3: event date was not provided so the publication date was used kawabata, t., iguchi, t., matsui, y., tomita, k., uka, m., umakoshi, n., and hiraki, t.(2024).Portal venous thrombosis after percutaneous cryoablation for renal cell carcinoma.

• Brand Name: ICESPHERE 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): GALIL MEDICAL LTD.; tavor building 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20016280
• Report Number: 2124215-2024-50248
• Device Sequence Number: 21001432
• Product Code: GEH
• UDI-Device Identifier: 07290104830945
• UDI-Public: 07290104830945
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: FPRPR3560
• Device Catalogue Number: FPRPR3560
• 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: 07/26/2024
• Initial Report FDA Received Date: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male