MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-08 for APOLLO WAND AP9 manufactured by Penumbra, Inc..
[107662631]
The product was disposed of by the hospital and is no longer available for return. Without the return of the device, the root cause of the problem cannot be determined. 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
[107662632]
The patient was undergoing a microneurosurgery procedure using an apollo wand (wand). During the procedure, the physician noticed the wand was leaking from the connection to the apollo generator during the foot pedal activation. It was also reported that the wire within the wand stopped vibrating toward the end of the procedure. The physician was able to remove most of the clot and the procedure was ended. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2018-00968 |
| MDR Report Key | 7496576 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-08 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-03-02 |
| Date Mfgr Received | 2018-04-11 |
| Device Manufacturer Date | 2017-08-10 |
| Date Added to Maude | 2018-05-08 |
| 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 | APOLLO WAND |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2018-05-08 |
| Catalog Number | AP9 |
| Lot Number | F78596 |
| ID Number | NI |
| Device Expiration Date | 2018-08-10 |
| 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 | 2018-05-08 |