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

Catalog Number	AP21
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left basal ganglia using an artemis neuro evacuation device (artemis).During the procedure, the physician used the artemis for approximately one hour.It was reported that the physician experienced difficulty while using the artemis to aspirate a dense thrombus.The penumbra sales representative then viewed the endoscope monitor and noticed that the bident was sticking out from the tip of the artemis hypotube.However, it was noted that the bident was still able to rotate.The artemis was then removed and was no longer used in the procedure.The procedure was completed using a new artemis.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the bident was protruding from the stainless steel hypotube approximately 1.0 mm.The pet tubing had slid approximately 1.5 mm from the motor.Conclusions: evaluation of the returned artemis handle confirmed the bident was protruding from the stainless steel hypotube.The pet tubing that joins the rotational motor to the wire assembly slid distally approximately 1.5 mm.The root cause of the pet tubing moving could not be determined.During functional testing, the handle was able to aspirate fluid and the rotational wire was functional.Penumbra artemis devices are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Results code 2: 4247 - the bident was protruding from the stainless steel hypotube and had slid from the motor.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the pet tubing moving.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8413024
• Report Number: 3005168196-2019-00465
• Device Sequence Number: 13522349
• Product Code: GWG
• UDI-Device Identifier: 00814548017860
• UDI-Public: 00814548017860
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: AP21
• Device Lot Number: S10001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005