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

Catalog Number	AP28
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
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 microneurosurgery procedure in a ventricle in the brain using an artemis neuro evacuation device (artemis).During the procedure, the physician was treating a hemorrhage using the artemis and reported that the artemis wand became clogged after evacuating half of the clot.It was also reported that the clot was very tough and organized.The physician was unable to unclog the artemis wand and it was therefore removed from 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 present inside the wand hypotube and was not protruding from the hypotube tip.Coagulated blood was present on the wand hypotube.Conclusions: evaluation of the returned artemis revealed the wand was not clogged upon return.During functional testing, the artemis device was able to aspirate fluid without issue.The device was deemed functional and the reported complaint could not be confirmed.Penumbra artemis devices are inspected during incoming inspection by quality.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
• MDR Report Key: 8498030
• Report Number: 3005168196-2019-00675
• Device Sequence Number: 13718823
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019
• 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: 11/20/2020
• Device Catalogue Number: AP28
• Device Lot Number: S10004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005