MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for ACCLARENT AERA EU061655 manufactured by Acclarent, Inc..
[88862231]
Patient Sequence No: 1, Text Type: N, H10
[88862232]
Surgeon was preparing the acclarent aera eustachian tube balloon catheter on the sterile back table to be sure device was functional. The staff and surgeon noted the balloon catheter was bent and the balloon ruptured when the surgeon began to fill the balloon. Company was notified immediately after the case about the defect. Manufacturer response: for eustachian tube balloon dilation device, acclarent aera (per site reporter) manufacturer was notified and send in a replacement device. Rep will pick up next time at our facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6935196 |
| MDR Report Key | 6935196 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-09-06 |
| Report Date | 2017-09-18 |
| Date Reported to FDA | 2017-09-18 |
| Date Reported to Mfgr | 2017-09-18 |
| Date Added to Maude | 2017-10-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCLARENT AERA |
| Generic Name | EUSTACHIAN TUBE BALLOON DILATION DEVICE |
| Product Code | PNZ |
| Date Received | 2017-10-10 |
| Model Number | EU061655 |
| Catalog Number | EU061655 |
| Lot Number | 160505B-PC |
| Device Expiration Date | 2018-05-04 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DR. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-10 |