VORTEX IRRIGATING CATHETER

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.