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 2016-12-02 for APOLLO WAND, SHORT AP7 manufactured by Penumbra, Inc..
[61403226]
Results: the apollo wand (wand) was slightly bent. Conclusions: evaluation of the returned device could not confirm the reported leak. The wand was connected to a demonstration apollo system and functionally tested. No leaks were observed during the functional test. Further evaluation revealed that the wand tip was slightly bent. The root cause of this damage could not be determined. All wands are visually inspected during in-process inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This report is associated with mfr report numbers: 3005168196-2016-01769.
Patient Sequence No: 1, Text Type: N, H10
[61403227]
The patient was undergoing a microneurosurgery procedure treating an intracranial hemorrhage (ich) using apollo wands (wands). During the procedure, while using the wand, the physician noticed there was a leak at the hub of the wand and it became clogged and unusable. The wand was therefore removed and the procedure was continued using a new wand. The physician reported that although the new wand was leaking as well; it was successfully used to complete the procedure. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2016-01768 |
| MDR Report Key | 6143541 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-02 |
| Date of Report | 2016-11-04 |
| Date of Event | 2016-11-04 |
| Date Mfgr Received | 2016-11-04 |
| Device Manufacturer Date | 2016-02-08 |
| Date Added to Maude | 2016-12-02 |
| 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 | 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, SHORT |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2016-12-02 |
| Returned To Mfg | 2016-11-30 |
| Catalog Number | AP7 |
| Lot Number | F67770 |
| ID Number | NI |
| Device Expiration Date | 2017-02-07 |
| 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 | 2016-12-02 |