MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-18 for AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM EU061655 manufactured by Acclarent, Inc..
[65572530]
Lot history record review was completed and confirmed that lot 160505b-pc met release specifications. The acclarent product analysis lab received the device for evaluation. When the investigation analysis is completed, a supplemental 3500a report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[65572531]
Acclarent was informed on (b)(6) 2016, of an event on (b)(6) 2016, in which the sterile package of an acclarent aera eustachian tube balloon dilation system 6x16mm (lot# 160505b-pc) was open. The sterility of the package was compromised. There was no report of patient injury or complication as the product was not used.
Patient Sequence No: 1, Text Type: D, B5
[67941544]
Acclarent received the returned aera eustachian tube balloon dilation system 6x16 mm device on 01/11/2017. Visual inspection was performed and the following observations were noted: there is a cut on the pouch (back side) measured 380 mm length. There is scratch on the baker card. The pouch still remains sealed. There is no damaged on the device. The top right side chevron showed a uniform sealing application (30 mm length). This issue was unlikely to have occurred during the manufacturing process at acclarent since all devices are manufactured and packaging in accordance with documented specifications and procedures and passed all required release criteria. In addition, on-line inspections are in place to prevent this type of defect prior leaving the facility. The failure mode of this complaint cannot be confirmed. Acclarent manufacturing processes can be ruled out as a potential cause of the alleged non-conformance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2017-00002 |
| MDR Report Key | 6261973 |
| Date Received | 2017-01-18 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-12-21 |
| Date Mfgr Received | 2016-12-21 |
| Date Added to Maude | 2017-01-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAQUIN KURZ |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497899383 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM |
| Generic Name | UNKNOWN |
| Product Code | PNZ |
| Date Received | 2017-01-18 |
| Returned To Mfg | 2017-01-11 |
| Model Number | NA |
| Catalog Number | EU061655 |
| Lot Number | 160505B-PC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-18 |