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 2017-04-18 for APOLLO WAND, LONG AP9 manufactured by Penumbra, Inc..
[73126282]
The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The product lot number was not provided, therefore, the manufacturing records could not be reviewed. The hospital disposed of the device.
Patient Sequence No: 1, Text Type: N, H10
[73126283]
The patient was undergoing a microneurosurgery procedure using an apollo wand (wand). During the procedure, the wand became clogged and the physician was unable to unclog it; therefore, the procedure was completed using a new wand. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2017-00623 |
| MDR Report Key | 6501581 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-18 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-23 |
| Date Added to Maude | 2017-04-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS 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 | APOLLO WAND, LONG |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2017-04-18 |
| Catalog Number | AP9 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-04-18 |