VORTEX IRRIGATING CATHETER

Additional Manufacturer Narrative

ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. THE SURGEON INDICATED THAT IRRIGATING CATHETER CAUSED A SMALL MUCOSAL TEAR AND IRRIGATING FLUID TRAVERSED INTO THE SOFT TISSUE. THE VP OF MEDICAL AFFAIRS CONCLUDED THAT THE EYE AND CHEEK SWELLING APPEARED TO COME FROM THE EXTRAVASATED IRRIGATION FLUID. THIS RESOLVED ON ITS OWN AND PRECAUTION WAS TAKEN TO OBTAIN AN OPTHALMAOLOGIC EXAMINATION AND OBSERVE AND KEEP THE PATIENT OVERNIGHT. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem

ACCLARENT WAS NOTIFIED ON (B)(6) 2013, OF AN EVENT THAT OCCURRED ON (B)(6) 2013, DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WERE USED. AN ACCLARENT SPIN DEVICE WAS USED TO DILATE RIGHT MAXILLARY SINUS WITH NO DIFFICULTY. THE ACCLARENT VORTEX IRRIGATING CATHETER WAS USED TO ENTER THE DILATED MAXILLARY SINUS OSTIA. WHEN INITIATING IRRIGATION, THE OPERATING ROOM ASSISTANT SAID THAT THE FLUID WAS GOING VERY SLOWLY AND WAS MEETING RESISTANCE. THE IRRIGATING CATHETER WAS PULLED BACK AND THE IRRIGATING FLUID ENTERED THE SINUS MORE EASILY. THE RIGHT CHEEK AND EYELID WERE NOTED SWELL. THE IRRIGATION WAS STOPPED. THE ENDOSCOPE REVEALED A SMALL TEAR IN THE MUCOSA OF THE ROOF OF THE MAXILLARY SINUS. THE SURGEON ASKED FOR AN OPHTHALMOLOGIST TO THE OPERATION ROOM AND FOUND THE INTRAOCULAR PRESSURES NORMAL. WITHIN 10 MINUTES, THE EYELID SWELLING BEGAN TO DIMINISH. THE PATIENT WAS KEPT OVERNIGHT AND BY THE NEXT DAY, NEARLY ALL OF THE SWELLING WAS GONE. THERE WAS NEVER ANY VISION CHANGE.