MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-07-22 for RELIEVA VORTEX IRRIGATION CATHETER LC7066 manufactured by .
[16564330]
The narrowed infundibular space was noted to make the physician's approach difficult. The sequelae suffered by the pt involved an overnight stay in the hospital and eye swelling, all of which resolved. The complaint history for eye swelling associated with acclarent devices has been noted as 0. 001%. No negative trends have been identified at this time. No product malfunction had occurred. Acclarent will continue to update the file with any add'l info and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
[16676024]
This event occurred during a procedure performed on (b)(6) 2011, with no product malfunction associated. The pt had bilateral hypo-plastic maxillary sinus procedure. A large quantity of calcified bone was noted while going into the maxillary sinus. Following the successful usage of the balloon catheter, the physician used an acclarent irrigation catheter (vortex) to irrigate. Upon irrigation, the physician noted swelling in the eye and immediately stopped the irrigation. Based upon feedback from the physician, the pt's narrowed infundibular space made the approach difficult, and that the lamina papyracea was probably violated by one of the tools used during the procedure. He noted that all devices performed as expected. An ophthalmologist was called into the operating room to address the swelling, and noted that although the pt's vision was normal, increased intraocular pressure was present. The pt was given diamox as a diuretic to reduce the intraocular pressure. The pt was kept overnight, and discharged the next day. The swelling had resolved upon f/u.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2011-00004 |
| MDR Report Key | 2187545 |
| Report Source | 07 |
| Date Received | 2011-07-22 |
| Date of Report | 2011-07-13 |
| Date of Event | 2011-05-09 |
| Date Added to Maude | 2012-06-19 |
| 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 | MARK BISHOP, VP |
| Manufacturer Street | 1525-B O'BRIEN DRIVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875843 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA VORTEX IRRIGATION CATHETER |
| Generic Name | VORTEX |
| Product Code | KAM |
| Date Received | 2011-07-22 |
| Model Number | VORTEX |
| Catalog Number | LC7066 |
| Lot 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-22 |