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 2016-12-30 for APOLLO PUMP APP1 manufactured by Penumbra, Inc..
[63654215]
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report number: 3005168196-2016-01891.
Patient Sequence No: 1, Text Type: N, H10
[63654216]
The patient was undergoing a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using the apollo system. During the procedure, the physician noticed that the apollo wand (wand) was leaking from the connection point to the apollo generator (generator) and also from the rotating hemostasis valve (rhv). Therefore, the physician switched to a new wand. It was also noticed that the regulator knob on the apollo pump (pump) was not working properly and just spun around without much effect on the aspiration power. However, the procedure was still completed using the same pump. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[70199466]
Please note that the serial # was inadvertently reported as the lot # on the initial mfr report and is being corrected on this follow up #1 mfr report. Results: there was no visible damage to the apollo pump (pump). Conclusions: evaluation of the returned device revealed that the wand? S rotating hemostasis valve (rhv) was leaking. The wand was connected to an apollo generator (generator) and during irrigation, a leak at the rhv was observed. The root cause of this failure could not be determined. Further evaluation of the returned devices revealed that the pump was functional. The pump was plugged in and powered on. The pump vacuum was able to be increased and decreased using the regulator knob without an issue. 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
| Report Number | 3005168196-2016-01892 |
| MDR Report Key | 6215857 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-30 |
| Date of Report | 2016-12-04 |
| Date of Event | 2016-12-04 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2015-02-13 |
| Date Added to Maude | 2016-12-30 |
| 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 PUMP |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2016-12-30 |
| Returned To Mfg | 2017-01-17 |
| Catalog Number | APP1 |
| Lot Number | F62692 |
| ID Number | NI |
| Operator | PHYSICIAN |
| 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 | 2016-12-30 |