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

Catalog Number	AP28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
On (b)(6) 2022, the patient underwent a micro neurosurgery procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).During the procedure, the physician noticed that there was no suction and that the artemis had become clogged after five minutes of use.Therefore, the artemis was removed.The procedure was completed using a new artemis.On (b)(6) 2023, a second notification was received from the clinical team reporting that an intraoperative computerized tomography (ct) scan taken on (b)(6) 2022 revealed a recurrent hemorrhage larger than the prior hemorrhage.The craniotomy was then extended, and navigation was used for a new entry point and craniotomy defect was enlarged.A full 3cm craniotomy was performed.The entry point was the superior frontal sulcus.Suction was advanced into the clot and used to remove the clot.Bipolar cautery was used for hemostasis.The recurrent hemorrhage was reported to be an adverse event with a possible relationship to the artemis and a possible relationship to the index procedure.
Additional Manufacturer Narrative
Intraventricular hemorrhage is included as possible complication in the instructions for use (ifu) for the artemis neuro evacuation device.Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was lost in transit and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text: placeholder.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16339687
• Report Number: 3005168196-2023-00071
• Device Sequence Number: 17725313
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 814548017877
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023
• Report Date (Section F): 01/01/2005

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: 02/15/2025
• Device Catalogue Number: AP28
• Device Lot Number: S10034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005