RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM

Additional Manufacturer Narrative

THE SUBJECT ACCLARENT DEVICE WAS NOT USED DURING A PATIENT PROCEDURE. A REPLACEMENT DEVICE WAS USED INSTEAD. THE SUBJECT DEVICE IS PENDING RETURN FOR EVALUATION. WHEN THE PRODUCT IS RETURNED AND TESTED, A SUPPLEMENTAL REPORT WILL BE FILED. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

Description of Event or Problem

ACCLARENT WAS INFORMED OF AN EVENT IN WHICH THE STERILE PACKAGE OF AN ACCLARENT RELIEVA LUMA SENTRY SINUS ILLUMINATION DEVICE WAS NOT FULLY SEALED. IT WAS REPORTED THAT WHEN PREPARING FOR A PROCEDURE, THE STAFF NOTICED THAT THE ADHESIVE BARRIER ON ONE OF THE CORNERS OF THE PACKAGING WAS COMPROMISED. THE PACKAGE WAS SUBSEQUENTLY OPENED COMPLETELY BY THE CUSTOMER. THE DEVICE WAS REMOVED FROM THE PACKAGING, BUT THE PRODUCT WAS NOT USED DURING THE PROCEDURE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING SET UP OF THE CASE, PRIOR TO THE SURGERY, THE SURGICAL TECHNICIAN WAS ABOUT TO OPEN THE GUIDE WIRE WHEN SHE NOTICED THAT THE LUMA GUIDE WIRE PACKAGING WAS COMPROMISED. ACCLARENT RECEIVED THE PACKAGE ON (B)(6) 2015, THE RETURNED PACKAGE INCLUDED LUMA SENTRY WIRE AND DETACHABLE CONNECTOR. THE PRODUCT WAS VISUALLY INSPECTED AND FOUND: THE BOTTOM OF THE POUCH REMAINS SEALED THE TOP CHEVRON SHOWS A UNIFORM SEALING APPLICATION TRACES OF FIBER ON THE PLASTIC FILM ON BOTH TOP LEFT AND TOP RIGHT CORNERS INDICATE THAT THE SEALING PROCESS AT THE TIME OF MANUFACTURING WAS PERFORMED UNIFORMLY AND CAUSED THE PLASTIC FILM TO ADHERE TO THE FIBER SURFACE. THE CREASES ON THE TOP LEFT AND TOP RIGHT CORNERS OF THE FIBER SEAL SURFACE SHOW THAT FORCES WERE APPLIED IN OPPOSITE DIRECTIONS IN ORDER TO BREAK THE SEALS, AND ARE INDICATIVE OF SEALING AT THE TIME OF MANUFACTURING. THE FAILURE MODE OF THIS COMPLAINT (POUCH WAS NOT SEALED IN THE UPPER RIGHT CORNER) CANNOT BE CONFIRMED.