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

Model Number AP28-A

Device Problems Decrease in Suction (1146); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

Results: there was no visible damage to the artemis neuro evacuation device (artemis) unit.There was some clotted blood present inside the aspiration chamber.Conclusions: evaluation of the returned artemis device revealed it was able to perform in all aspects within specification.When activating the rotational wire the noise varied noticeably.The change in noise did not affect the function of the device.The root cause of the changes in sound produced by the handle could not be determined.Penumbra artemis 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.

Event Description

The patient was undergoing a microneurosurgery procedure using an artemis neuro evacuation device (artemis).During the procedure, the physician noticed that there was a decrease in aspiration power and decreased audible and tactile feedback after about 15 minutes of use.The physician therefore flushed the cannula with saline and cleared the aspiration tubing, however no improvement was noticed.The procedure was therefore completed using a new artemis.There was no report of an adverse effect to the patient.

Manufacturer Narrative

(b)(4).

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7220369
• MDR Text Key: 98429621
• Report Number: 3005168196-2018-00220
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (y/n): Y
• PMA/PMN Number: K171332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/13/2020
• Device Model Number: AP28-A
• Device Catalogue Number: AP28
• Device Lot Number: S10002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 119