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 2017-08-21 for APOLLO WAND AP7 manufactured by Penumbra, Inc..
[83243596]
(b)(4). Results: the sonic wire on the apollo wand (wand) was protruding out the distal tip of the wand. The sonic wire was fractured at the connection to the sonic connector in the abs knob on the proximal end of the wand. Conclusion: evaluation of the returned device revealed that a loud sound was heard and the sonic wire was protruding out the distal tip of the wand during the functional analysis. The wand was connected to the generator and powered on. The wand irrigated and aspirated without an issue. However, while depressing the foot pedal a loud sound was observed and the sonic wire began to protrude out the distal tip of the wand. Further evaluation of the returned device revealed that the sonic wire was fractured at the connection to the sonic connector in the abs knob. Extended use of the wand could cause heat to build up at the sonic connector, which may contribute to the sonic wire fatigue. The root cause of the loud noise that was heard during the procedure could not be determined. Penumbra devices are visually inspected during in-process inspection and during quality inspection after manufacturing. 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
[83243597]
The patient was undergoing a microneurosurgery procedure to treat an intra-cerebral hemorrhage (ich) using an apollo wand (wand). During the procedure, after a few minutes of use, a loud noise was heard. The penumbra sales representative inspected the wand? S connection to the apollo generator (generator), and found that the black connector had become loose due to the vibration of the machine. The sales representative tightened the black connector, and felt that it had become very hot. The black connector was unable to stay tight; therefore, the sales representative held the black connector in place as the procedure continued. The noise continued and there was still a considerable amount of heat at the black connector, and so at this point the physician removed the wand from the patient and found that the vibration wire was protruding and was exposed outside of the tip of the wand. The wand was therefore not reused, and the procedure was completed using a new wand and the same generator. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2017-01402 |
| MDR Report Key | 6807338 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-21 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2017-02-23 |
| Date Added to Maude | 2017-08-21 |
| 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 | 2017-08-21 |
| Returned To Mfg | 2017-08-03 |
| Catalog Number | AP7 |
| Lot Number | F74564 |
| ID Number | NI |
| Device Expiration Date | 2018-02-23 |
| 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 | 2017-08-21 |