MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	IB-CON
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Liver Failure (4492); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/30/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation into potential device involvement, device performance, and contributing factors is ongoing.At this time, no conclusions have been reached.
Event or Problem Description
A varian clinical science liaison (csl) was notified on (b)(6) 2026 of a patient who experienced issues following a microwave ablation procedure performed on (b)(6) 2026.The treating physician informed the csl the patient had a ¿much larger¿ ablation zone than what was predicted.The physician stated the patient had issues post procedure and in further talks with the hospital staff present, the csl was informed the patient passed away.A csl, who was present during the procedure on (b)(6) 2026, provided details regarding the procedure on (b)(6) 2026.It was confirmed the physician used the myablation guide software (¿mag¿) to locate and target a difficult-to-reach lesion from an extremely acute and off-plane approach.The physician, at the time of the procedure, seemed very pleased with the needle planning, and guidance from the mag perspective.The intelliblate system did not show abnormal temperature charts, and the treatment protocol was consistent with treating the lesion with appropriate sizing.The csl was not present for the post-procedure scan.Additional questions regarding the procedure and patient outcome were requested.The treating physician confirmed on (b)(6) 2026 that the larger ablation resulted in a liver infarction that led to liver failure and subsequent multi-organ system failure.The physician confirmed the ablation was performed with no technical issues.The positioning of the xpa microwave probes was stated by the treating physician to be ¿perfect¿, and the operation of the microwave console was as expected.
Event or Problem Description
See completed (b)(4) and mfr 3008262715-2026-0007.
Additional Manufacturer Narrative
This supplemental submission includes details obtained upon completion of the investigation.The investigation and corresponding investigation codes were finalized at investigation closure on april 30, 2026.Manufacturer narrative includes investigation conclusion: the reported complaint did not identify a device malfunction.The device was not available for evaluation, as the event was reported several weeks after the procedure.Review of available ablation system data showed changes in power settings during the procedure, with corresponding expected changes in temperature output.Device history record review for the applicable lot confirmed the product met all functional and electrical requirements.Based on the available information, the investigation determined that the intelliblate system performed as intended.The patient death was due to the circumstances of the ablation case and not caused by the performance of the intelliblate system.

• Brand Name: INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 9825 spectrum dr. bldg 2; austin TX 78717
• Manufacturer Contact: nia van baalen ; 9825 spectrum dr. bldg 2; austin, TX 78717 ; 6504246833
• MDR Report Key: 24914861
• Report Number: 3008262715-2026-00007
• Device Sequence Number: 18624135
• Product Code: NEY
• UDI-Device Identifier: 00810563022278
• UDI-Public: (01)00810563022278(11)241216
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/13/2026

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: IB-CON
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Death
• Patient Sex: Unknown