MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-27 for VORTEX IRRIGATING CATHETER LC7065 manufactured by Acclarent Inc.
[18310701]
Acclarent was notified on (b)(4) 2013 of an event that occurred on (b)(6) 2013 during a sinus surgical case when acclarent vortex irrigation catheter was used. The pt required bilateral frontal sinus and maxillary sinus balloon dilation, along with a completion ethmoidectomy with a shaver. The acclarent vortex irrigating catheter was used with a small amount of saline instilled. While irrigating the left maxillary sinus, there was some eyelid swelling. There was no change in vision. A ct scan was obtained and showed the post operative surgical changes but no breach in the lamina papyrecea. Some fluid was seen in the orbital preseptal space. There was no intervention of any kind. After few hours the orbital swelling resolved. The surgeon reported the pt has done well with no problems.
Patient Sequence No: 1, Text Type: D, B5
[18323930]
Acclarent followed up on this report to gather additional information. The surgeon reported that the acclarent devices functioned without difficulty or problem. The surgeon indicated that irrigating catheter caused some saline to track beneath the mucosa of the ethmoid or maxillary sinus resulting in the swelling. The subject device of this report was not returned for evaluation, and its whereabouts are unk. Acclarent will continue to monitor this phenomenon for trending purposes. This report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2013-00013 |
| MDR Report Key | 3037396 |
| Report Source | 05 |
| Date Received | 2013-03-27 |
| Date of Report | 2013-03-06 |
| Date of Event | 2013-03-06 |
| Date Mfgr Received | 2013-03-06 |
| Date Added to Maude | 2013-04-08 |
| 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, DIRECTOR |
| Manufacturer Street | 1525-B O'BRIEN DRIVE |
| 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 | VORTEX IRRIGATING CATHETER |
| Generic Name | IRRIGATION CATHETER |
| Product Code | KAM |
| Date Received | 2013-03-27 |
| Model Number | NA |
| Catalog Number | LC7065 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-03-27 |