MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-14 for ARTEMIS NEURO EVACUATION DEVICE AP28 manufactured by Penumbra, Inc..
[93079122]
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.
Patient Sequence No: 1, Text Type: N, H10
[93079123]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2017-01964 |
| MDR Report Key | 7031423 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-14 |
| Date of Report | 2017-10-15 |
| Date of Event | 2017-10-15 |
| Date Mfgr Received | 2017-10-15 |
| Device Manufacturer Date | 2017-08-14 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VERONICA FARRIS |
| Manufacturer Street | ONE PENUMBRA PLACE |
| Manufacturer City | ALAMEDA CA 94502 |
| Manufacturer Country | US |
| Manufacturer Postal | 94502 |
| Manufacturer Phone | 5107483200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTEMIS NEURO EVACUATION DEVICE |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2017-11-14 |
| Returned To Mfg | 2017-10-18 |
| Catalog Number | AP28 |
| Lot Number | S10002 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENUMBRA, INC. |
| Manufacturer Address | ONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-14 |