RELIEVA VORTEX IRRIGATION CATHETER

Additional Manufacturer Narrative

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.

Description of Event or Problem

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.