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 2016-12-06 for APOLLO IRRIGATION TUBING APTUBE1 manufactured by Penumbra, Inc..
[61597047]
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
[61597048]
The patient was undergoing a microneurosurgery procedure to treat a ventricular hemorrhage using the apollo system. During the procedure, the wand was making a lot of noise and seemed to not be working well. It was noted that the ventricular clot was thick and the wand did not seem to break it well and the aspiration seemed less than what was expected. The nurse then removed the apollo irrigation tubing (irrigation tubing) from the console and covered the aspiration port with a finger and noticed that the dial was at -20 inhg. When the irrigation tubing was connected back to the console, the aspiration pressure was at? 25 inhg. It was reported that the wand also made a screeching high pitch noise; therefore, it was removed and a new wand was opened. The nurse then experienced difficulty while attempting to connect the irrigation tubing to the new wand and consequently, the irrigation tubing became contaminated. Therefore, the irrigation tubing was removed and a new irrigation tubing was opened. It was also noted that the protective cap (red with a wing shaped end) was very difficult to remove. After that, the procedure was completed with no complications and there was no report of an adverse effect to the patient
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2016-01794 |
| MDR Report Key | 6149900 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-06 |
| Date of Report | 2016-11-11 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2016-11-11 |
| Date Added to Maude | 2016-12-06 |
| 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 IRRIGATION TUBING |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2016-12-06 |
| Catalog Number | APTUBE1 |
| 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 | 2016-12-06 |