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 2018-01-25 for ARTEMIS NEURO EVACUATION DEVICE AP28 manufactured by Penumbra, Inc..
[98429621]
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.
Patient Sequence No: 1, Text Type: N, H10
[98429622]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2018-00220 |
| MDR Report Key | 7220369 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-25 |
| Date of Report | 2017-12-29 |
| Date of Event | 2017-12-29 |
| Date Mfgr Received | 2017-12-28 |
| Device Manufacturer Date | 2017-08-17 |
| Date Added to Maude | 2018-01-25 |
| 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 |
| Manufacturer G1 | PENUMBRA, INC. |
| Manufacturer Street | ONE PENUMBRA PLACE |
| Manufacturer City | ALAMEDA CA 94502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94502 |
| 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 | 2018-01-25 |
| Returned To Mfg | 2018-01-11 |
| Catalog Number | AP28 |
| Lot Number | S10002 |
| 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 | 2018-01-25 |