RELIEVA FLEX SINUS GUIDE CATHETER

Description of Event or Problem

IT WAS REPORTED THAT AFTER DILATING THE RIGHT MAXILLARY SINUS THE PHYSICIAN WAS ABOUT TO INSERT THE DEVICE INTO THE LEFT MAXILLARY SINUS WHEN IT WAS OBSERVED THAT THE BLUE TIP OF THE SINUS GUIDE CATHETER WAS MISSING. THE PHYSICIAN EXAMINED THE RIGHT MAXILLARY SINUS. THE USER REPORTED THAT THE TIP WAS LOCATED INSIDE A BLOOD CLOT THAT HAD ALREADY BEEN REMOVED FROM THE PT EARLIER IN THE SAME PROCEDURE. THE GUIDE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

Additional Manufacturer Narrative

THE DEVICE REFERENCED IS BEING RETURNED FOR EVAL. REVIEW OF MFG RECORDS ASSOCIATED WITH THE SUBJECT DEVICE DID NOT DETECT ANY ANOMALIES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE EVAL FOLLOWING RECEIPT OF THE DEVICE. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.