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

Catalog Number AP28

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

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.(b)(4).

Event Description

The patient was undergoing a microneurosurgery procedure using an artemis neuro evacuation device (artemis).During the procedure, the physician noticed that the artemis bident did not function when the device was activated.Additionally, it was noted that the artemis did not make any noise.The physician then decided to end the procedure and bring the patient back in the next day for an open procedure.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the was no visible damage to the artemis.Conclusions: evaluation of the returned artemis revealed a functional device.The artemis was connected to a pump max.The pump max was powered, and the artemis was able to aspirate without an issue.In addition, the red button was depressed on the artemis and the bident wire was observed vibrating inside the tube.The root cause of the reported complaint 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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9261347
• MDR Text Key: 164493744
• Report Number: 3005168196-2019-02009
• Device Sequence Number: 1
• Product Code: GWG
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/01/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: AP28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1