VORTEX IRRIGATING CATHETER

Description of Event or Problem

THE SURGEON REPORTED THAT DURING A BALLOON SINUPLASTY PROCEDURE IN INDIA, THE SUBJECT DEVICE WAS USED IN A PT WITH OSTIOMEATAL COMPLEX OBSTRUCTION AND SINUSITIS WITH COMPLETE OPACIFICATION OF THE RIGHT MAXILLARY SINUS. AFTER THE MAXILLARY DILATION PROCEDURE AND IRRIGATION, THICK VISCID MATERIAL CAME OUT OF THE MAXILLARY SINUS AND PT IMMEDIATELY DEVELOPED PROPTOSIS OF THE RIGHT EYE. A MEDIAL DECOMPRESSION OF THE ORBIT CARRIED OUT TO RELIEVE EYE PRESSURE. PT WAS GIVEN A DOSE OF INTRAVENOUS METHYL PREDNISOLONE AND THE PT WAS OBSERVED FOR THREE DAYS AND DISCHARGED. THE PT WAS FOLLOWED UP AFTER 10 DAYS AND THERE WERE NO LONG TERM SEQUELAE.

Additional Manufacturer Narrative

ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFO. A RETROSPECTIVE REVIEW OF THE CT SCANS BY RADIOLOGIST REVEALED THAT THERE WAS A DEHISCENCE IN THE ANTERIOR PART OF THE LAMINA WITH GENERAL THINNING OF THE BONE. THIS WAS MOST LIKELY CAUSED BY THE CHRONIC INFECTION IN THE REGION. THE SURGEON REPORTED THAT THE ORBITAL SWELLING WAS IN NO WAY CAUSED BY THE ACCLARENT TOOLS WHICH PERFORMED SATISFACTORILY. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVAL, AND ITS WHEREABOUTS ARE UNK. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THE VORTEX INSTRUCTIONS FOR USE STATE, UNDER THE WARNINGS SECTION, "TO PREVENT INADVERTENT FLUID EXTRAVASATION, SUCH AS INTO THE ORBIT, DO NOT IRRIGATE IN THE PRESENCE OF A BONY DEHISCENCE OR DEFECT IN ANY SINUS WALL." THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.