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 2019-04-09 for ARTEMIS NEURO EVACUATION DEVICE AP28 manufactured by Penumbra, Inc..
[141456012]
The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10
[141456013]
The patient was undergoing a microneurosurgery procedure in a ventricle in the brain using an artemis neuro evacuation device (artemis). During the procedure, the physician was treating a hemorrhage using the artemis and reported that the artemis wand became clogged after evacuating half of the clot. It was also reported that the clot was very tough and organized. The physician was unable to unclog the artemis wand and it was therefore removed from the procedure. The procedure was 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 | 3005168196-2019-00675 |
| MDR Report Key | 8498030 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-09 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-03-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-07-11 |
| Device Manufacturer Date | 2017-11-20 |
| Date Added to Maude | 2019-04-09 |
| 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 | 2019-04-09 |
| Returned To Mfg | 2019-04-08 |
| Catalog Number | AP28 |
| Lot Number | S10004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-09 |