RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER

Description of Event or Problem

ACCLARENT WAS NOTIFIED ON (B)(6) 2014, OF A DOMESTIC EVENT THAT OCCURRED DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE PATIENT HAD EXPERIENCED RIGHT EYE SWELLING DURING A BALLOON SINUPLASTY PROCEDURE. THIS WAS THE FIRST SINUS TREATED. THE DOCTOR DID NOT GET LIGHT CONFIRMATION AND WAS HAVING DIFFICULTY ADVANCING THE BALLOON AND VORTEX CATHETER. THE SALINE INJECTED INTO THE ORBIT DURING IRRIGATION. NO OTHER PROCEDURES WERE CONDUCTED AT THAT TIME AND THERE WAS NO SURGERY REQUIRED TO REDUCE SWELLING.

Additional Manufacturer Narrative

VP OF MEDICAL AFFAIRS TRIED TO CONTACT THE TREATING PHYSICIAN BY PHONE THREE TIMES BUT DID NOT RECEIVE ANY RESPONSE. BASED ON THE INFORMATION PROVIDED, THERE WAS NOT ENOUGH INFORMATION TO DETERMINE IF ACCLARENT DEVICES CAUSE OR CONTRIBUTE TO THE EVENT. THERE WAS NO INFORMATION PROVIDED IF OTHER MEDICAL INTERVENTION (E.G. INTRAVENOUS STEROID) WAS PERFORMED. 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.