RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER
Received May 5, 2016 · Event occurred Apr 12, 2016
Report 3005172759-2016-00009 · MDR key 5636007
Device
Generic name
Irrigator, Sinus
Manufacturer
Acclarent, Inc.Model number
N/ACatalog number
RV02
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4). THE LHR (LOT HISTORY RECORD) REVIEW CANNOT BE PERFORMED AS LOT NUMBER WAS UNAVAILABLE.
Description of Event or Problem
ACCLARENT WAS INFORMED OF AN EVENT THAT OCCURRED ON (B)(6) 2016, INVOLVING A RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER. THE PHYSICIAN ATTEMPTED TO IRRIGATE THE MAXILLARY SINUS AND THE PATIENT'S ORBIT STARTED TO SWELL. THE PHYSICIAN IMMEDIATELY CEASED THE IRRIGATION AND PLACED PRESSURE ON THE EYE. THE OPHTHALMOLOGIST EXAMINED THE PATIENT AND CONFIRMED THAT THERE WAS NO DAMAGE TO THE EYE. THE PATIENT WAS FINE AND THE PROCEDURE WAS COMPLETED. ACCLARENT TRIED TO FIND OUT ADDITIONAL PATIENT INFORMATION; ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTION.