MULTIPLE DEVICES (REF H.10)

Additional Manufacturer Narrative

NO SPECIFIC DEVICE WAS ATTRIBUTED TO THE BLEEDING, HOWEVER, A REVIEW OF THE LOT INFO FOR LUMA (LOT #091228C), GUIDE CATHETER (091217A), SOLO PRO (091120A), VORTEX (091030F-CM), FRONTAL SPACER (100106A), AS WELL AS HISTORICAL TRENDING WAS PERFORMED. THE LOTS MET SPECIFICATION, AND NO SIGNIFICANT TRENDS WERE NOTED. NO PRODUCT MALFUNCTION WAS NOTED. THE DEVICES WERE NOT AVAILABLE FOR RETURN. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

Description of Event or Problem

THIS EVENT OCCURRED IN ONE PT. ON (B)(6) 2010, CUSTOMER SERVICE WAS NOTIFIED OF AN EVENT WHICH INVOLVED BLEEDING FROM THE ANTERIOR ETHMOID ARTERY FOLLOWING BALLOON SINUPLASTY/SPACER IMPLANTATION ON A PT'S LEFT FRONTAL SINUS. THE ENT CONSULTANT WAS LATER NOTIFIED OF 2 POST-OPERATIVE SURGICAL INTERVENTIONS, WHEREBY THE PT WAS TAKEN BACK TO SURGERY TWICE TO MANAGE THE BLEEDING. AT THIS TIME, (B)(6) 2010, THE COMPLAINT WAS CATEGORIZED AS AN MDR. THE PROCEDURE PERFORMED INVOLVED A 7X24MM SOLO PRO, FOLLOWING DEBRIDEMENT (REMOVAL OF TISSUE WITH A NON-ACCLARENT SHAVER) NEAR THE FRONTAL DUCT. FOLLOWING THE BALLOON SINUPLASTY, USE OF VORTEX IRRIGATION WAS USED, AS WELL AS DEPLOYMENT OF A STRATUS FRONTAL SPACER. THE ENT CONSULTANT NOTED NO BLEEDING FOLLOWING USE OF ACCLARENT DEVICES. THE ENT CONSULTANT NOTED THAT THE PHYSICIAN DECIDED TO FURTHER TREAT THE PT AFTER TREATING THE FRONTAL SINUS, BUT THE TYPE OF TREATMENT WAS NOT DISCLOSED TO THE ENT CONSULTANT. LATER THAT DAY, THE PT RETURNED TO THE HOSPITAL WITH CONCERNS OF BLEEDING. THE PHYSICIAN ATTEMPTED TO CAUTERIZE THE SITE, AND HAD THOUGHT IT HAD BEEN SUCCESSFUL. LATER THAT WEEK, THE PT RETURNED WITH FURTHER BLEEDING. AT THIS POINT, THE PHYSICIAN USED AN EXTERNAL APPROACH INVOLVING AN INCISION AND CLIP ON THE ANTERIOR ETHMOID ARTERY. THIS INTERVENTION WAS SUCCESSFUL. NO FURTHER BLEEDING WAS NOTED BEYOND THIS POINT. FOLLOW UP WITH THE PHYSICIAN WAS MADE TWICE, AND AS OF (B)(6) 2010, THE PT WAS NOTED TO BE FINE.