RELIEVA STRATUS DEPLOYMENT GUIDE

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A BI-LATERAL ETHMOID SINUS PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE AN ETHMOID SINUS SPACER IN THE RIGHT SIDE, HOWEVER, THE SPACER DEPLOYMENT GUIDE DEFLECTED OFF OF UNEXPECTEDLY HARD BONE, AND INADVERTENTLY PERFORATED THE POSTERIOR ETHMOID ROOF. THE PHYSICIAN IMMEDIATELY DETECTED A CSF LEAK, AND THE PT WAS TREATED WITH A MUCOSAL GRAFT AND TISSUE GLUE WERE APPLIED. THE PT WAS KEPT OVERNIGHT, AND DISCHARGED THE FOLLOWING MORNING. ON F/U SIX DAYS LATER, THE PT WAS SAID TO BE DOING WELL.

Additional Manufacturer Narrative

ACCLARENT F/U ON THIS REPORT TO GATHER ADD'L INFO ON (B)(4) 2010. THE PHYSICIAN INDICATED THAT HE BELIEVED THE PT'S ANATOMY WAS THE CAUSE OF THE REPORTED DIFFICULTY, AS THE PT HAD DENSE BONE AND A PLATE THAT WAS DIFFICULT TO ASSESS ON CT SCAN. THE ANATOMY REPORTEDLY DEFLECTED THE TRAJECTORY OF THE GUIDE INTERNALLY. THE DEVICE IN THE REPORTED EVENT WAS NOT RETURNED FOR EVAL AND ITS WHEREABOUTS IS UNK. PRODUCTION RECORDS WERE REVIEWED AND NO DEVIATIONS WERE NOTED THAT WOULD LIKELY CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.