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

Catalog Number AP28

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

Results: upon first evaluation, significant clot burden was observed inside the artemis neuro evacuation device (artemis) hypotube.The location of the distal end of the wire was within specification.During functional analysis, the artemis was connected with a demonstration pump max.Upon depressing the artemis button, the wire rotated as intended.The pump max was powered on, and the observed vacuum level was less than -25inhg.Water was aspirated through the artemis, and significant clot burden was removed from the hypotube.Upon removing the clot burden from the hypotube, the vacuum level returned to -25inhg, and the artemis functioned as intended.Following functional analysis, the artemis was opened by penumbra engineers and there was no visible damage to the artemis.Conclusions: evaluation of the returned device revealed that significant clot burden was partially occluding the hypotube.The observed partial occlusion reduced the vacuum level through the artemis.When the occlusion was cleared by aspirating water through the artemis, the vacuum level returned to -25inhg.Partial occlusion of the hypotube likely contributed to the reported issues with not performing to maximum aspiration.The critical dimensions of the artemis were within specification, and the device functioned as intended.Penumbra artemis devices are visually and functionally inspected during incoming quality inspection.The testing and inspection records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing microneurosurgery procedure to treat a basal ganglia hematoma using the artemis neuro evacuation device (artemis).During the procedure, while using the artemis with a penumbra system aspiration pump max 110v (pump max), the physician noticed that the artemis seemed to be "underpowered" and not performing to its max aspiration.Therefore, the artemis was removed and a new artemis was opened but the physician indicated that the new artemis felt the same as the first one.Although the second artemis seemed to be "underpowered", the physician successfully completed the procedure using the second artemis and the same pump max.It is unclear if the artemis was in fact "underpowered" or if the clot was just tenacious and not able to be evacuated.It should be noted that there was no reported issue with the pump max.Additionally, there was no report of an adverse effect to the patient.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Type of Device: 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: 7031423
• MDR Text Key: 93079122
• Report Number: 3005168196-2017-01964
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/13/2020
• Device Catalogue Number: AP28
• Device Lot Number: S10002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR