MAUDE Adverse Event Report: PENUMBRA, INC. ARTEMIS NEURO EVACUATION DEVICE; GWG

Catalog Number	AP28
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a microneurosurgery procedure using an artemis neuro evacuation device (artemis).The case was nearly complete when the artemis became clogged after approximately ninety minutes of use.At that point, the physician realized they were on the wrong trajectory and noticed a vessel injury to the right a2 segment of the anterior cerebral artery (aca).The clogged artemis was removed and replaced with a new device, and the procedure was successfully completed.To address the vessel injury, the physician performed irrigation and electro-cautery.No additional information was provided regarding the patient status.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that the following sections are updated on this follow up #1 mfr report: 1.Section h.Box 6.Health effect clinical code 1.2.Section h.Box 6.Health effect impact code 1 & health effect impact code 2.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Evaluation of the returned artemis neuro evacuation device (artemis) could not confirm the reported clog.Evaluation revealed an undamaged, functional device.During evaluation, fluid was aspirated through the artemis, and the bident rotated without an issue when the power button was pressed.Penumbra devices are inspected at incoming quality control which includes a visual inspection as well as a verification of test results to ensure specifications for each output are met.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23936906
• Report Number: 3005168196-2025-00420
• Device Sequence Number: 21200646
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K171332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AP28
• Device Lot Number: S10045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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: 59 YR
• Patient Sex: Male