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Description of Event or Problem

THIS EVENT OCCURRED IN ONE PT. ACCLARENT WAS MADE AWARE OF THIS EVENT ON 4/12/2010. A PT HAD A CSF-LEAK IN THE RIGHT FRONTAL SINUS AFTER A HYBRID CASE INVOLVING FESS, AN ANTERIOR ETHMOIDECTOMY, AS WELL AS BALLOON SINUPLASTY. THE COMPLAINT INFORMATION NOTED PLACEMENT OF THE SOLO PRO BALLOON IN THE RIGHT FRONTAL SINUS APPEARED ODD. CONSEQUENTLY, THE SURGEON PERFORMED A CT SCAN, CONCLUDING THE GUIDEWIRE AND BALLOON WERE ADVANCED POSTERIOR TO THE FRONTAL SINUS. THE PT WAS TREATED WITH GEL FOAM AND GLUE TO RESOLVE THE LEAK. THE PT WAS PLACED WITH A LUMBAR DRAIN. NO EVIDENCE OF A PERSISTENT LEAK WAS NOTED SHORTLY THEREAFTER.

Additional Manufacturer Narrative

THE INFORMATION AVAILABLE DID NOT MENTION WHETHER THE PT HAD A PREVIOUS HISTORY OF INJURY, OR ANY PRE-EXISTING ANATOMICAL DEFECTS. IT DID, HOWEVER, STATE THAT THE PT HAD A LONGER THAN NORMAL UNCINATE PROCESS, IN ADDITION TO A SMALL RIGHT FRONTAL SINUS IN RELATION TO THE LEFT FRONTAL SINUS. IT IS UNK WHAT OTHER SURGICAL INSTRUMENTS MAY HAVE BEEN USED TO PERFORM THE ETHMOIDECTOMY NOTED IN THE COMPLAINT REPORT. A REVIEW OF THE HISTORICAL TRENDING WAS PERFORMED FOR CSF LEAK, AND NO SIGNIFICANT TRENDS WERE NOTED. IN ADDITION, NO PRODUCT MALFUNCTION WAS NOTED. THE LOT INFORMATION WAS NOT AVAILABLE. NO DEVICE (S) WERE AVAILABLE FOR RETURN. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFORMATION AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.