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Description of Event or Problem

THIS EVENT OCCURRED IN ONE PT APPROXIMATELY 6 MONTHS PRIOR TO ACCLARENT'S AWARENESS OF THIS EVENT. ACCLARENT BECAME AWARE OF THIS EVENT ON (B) (6) 2010. A PT HAD A CSF-LEAK IN THE FRONTAL SINUS AFTER A HYBRID CASE INVOLVING FESS, AS WELL AS BALLOON SINUPLASTY WITH A SOLO BALLOON CATHETER. THE INFORMATION PROVIDED STATED THAT THE SOLO BALLOON CATHETER WAS NOT PLACED WITH AN ACCLARENT GUIDE CATHETER, BUT RATHER, THRU A SUCTION DEVICE, WITHOUT THE GUIDANCE OF A GUIDEWIRE. UPON NOTING THE CSF LEAK, THE PT WAS HOSPITALIZED. RESOLUTION OCCURRED SHORTLY THEREAFTER.

Additional Manufacturer Narrative

THE INFORMATION AVAILABLE DID NOT MENTION WHETHER THE PT HAD ANY PREDISPOSING ANATOMICAL DEFECT, INJURY HISTORY, OR OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE INJURY. 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.