MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INTELLIBLATE XIMITRY PROBE ASSEMBLY 20CM

Model Number	IB-XPA-1320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Liver ablation of a small hcc mass using the intelliblate system and associated ximetry probe assembly.Placement of a single xpa and the ablation was performed with no issues.Following the ablation, the post ct scan showed evidence of active hemorrhage.Patient was moved to the angiography suite where an angiogram identified the source of bleeding.The pseudo aneurysm was successfully embolized and the patient was discharged the following day on (b)(6).Dr.Reports on (b)(6) that the patient is doing well.
Additional Manufacturer Narrative
Customer reported a patient experienced an active hemorrhage as evidenced by a ct scan post microwave ablation procedure of a small hcc mass on (b)(6) 2024.Angiogram was immediately performed to identify the source of the bleeding and an additional embolization procedure was successfully conducted to address a pseudo aneurysm.Patient was discharged the following day, on (b)(6) 2024 and physician reports the patient is recovering.No allegation of malfunction is reported against the intelliblate ximitry probe as the reporter confirmed the initial ablation procedure was performed without issue.Varian medical professional provided a medical review of the event on 29/oct/2024 and determined that the information reasonably suggests that the varian device has or may have caused or contributed to a serious injury.Given that unexpected medical intervention was required after the ablation procedure, this event is deemed a serious injury.Bleeding/hemorrhage from a pseudoaneurysm or otherwise, is a known potential complication with puncture of the liver by a device such as a needle or probe.
Event or Problem Description
See completed (b)(4).
Additional Manufacturer Narrative
Additional information provided in h6.Our investigation determined that the microwave probe functioned as intended, and the device was not returned for evaluation.A review of manufacturing and product records did not reveal any defects or nonconformities that could have contributed to the event.Hemorrhage is a known procedural risk associated with microwave ablation and not indicative of device malfunction.Therefore, no corrective or preventive actions are warranted at this time.

• Brand Name: INTELLIBLATE XIMITRY PROBE ASSEMBLY 20CM
• Common Device Name: INTELLIBLATE XIMITRY PROBE ASSEMBLY 20CM
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 9825 spectrum drive; bldg 2; austin TX 78717
• Manufacturer (Section G): VARIAN MEDICAL SYSTEMS; 9825 spectrum drive; bldg 2; austin TX 78717
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 20582491
• Report Number: 3008262715-2024-00001
• Device Sequence Number: 8714400
• Product Code: NEY
• UDI-Device Identifier: 00810563022308
• UDI-Public: (01)00810563022308(11)240815(17)250211(10)31385
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K240480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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 Expiration Date: 02/11/2025
• Device Model Number: IB-XPA-1320
• Device Lot Number: 31385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Life Threatening
• Patient Sex: Unknown