MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2013-04-02 for RELIEVA BALLOON UNK manufactured by Acclarent, Inc..
[16223069]
Acclarent was made aware of this event on (b)(6) 2013 when a literature search was being conducted by an acclarent employee. In the article, an acclarent balloon sinuplasty was performed and an acclarent ethmoid spacer was inserted. A subperiosteal hematoma developed in the roof of the orbit resulting in temporary diplopia. The hematoma was located only in the subperiosteal space at the roof of orbit. The authors postulate that the unusual perforations in the anterior orbital roof became sheared from the pressure of the bsp balloon transmitted through osteoneogenic thickened bone. The authors state that subperiosteal hematoma are unusual and occur with minor trauma around the orbit. He also stated that the location of the hematoma in the superior orbital submucosal space was evidence of trauma from the balloon use in the frontal sinus. The acclarent ethmoid spacer could not contribute to the pathology since the spacer was a significant distance away from the region of the hematoma. The surgeon stated that there was no breach in the bone of the sinuses. There was no intervention and the eye problem resolved with watchful waiting.
Patient Sequence No: 1, Text Type: D, B5
[16428548]
The author of the article has been contacted by vp of medical affairs by phone on (b)(6)2013. The surgeon stated that the location of the hematoma in the superior orbital submucosal spacer was evidence of trauma from the balloon used in the frontal sinus. Acclarent ethmoid spacer could not contribute to the event since the spacer was significant distance away from the region of the hematoma. The surgeon stated that no treatment or intervention and the eye problem resolved with no sequelae. This report is being submitted in an abundance of caution. The subject device of this report was not returned for evaluation, and its whereabouts are unknown. Acclarent will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2013-00014 |
| MDR Report Key | 3041993 |
| Report Source | 03 |
| Date Received | 2013-04-02 |
| Date of Report | 2013-03-08 |
| Date Mfgr Received | 2013-03-08 |
| Date Added to Maude | 2013-04-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOOSHIN ASBAGH |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875398 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA BALLOON |
| Generic Name | SINUS BALLOON CATHETER |
| Product Code | KAM |
| Date Received | 2013-04-02 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-02 |