EMBOSPHERE

Additional Manufacturer Narrative

THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT MEETS FDA CRITERIA FOR REPORTING. THE REPORT IS BEING SUBMITTED TO ENSURE ACCURACY AND COMPLETENESS OF MDR FILES. THIS SUBMISSION DOES NOT REFLECT A CHANGE IN DEVICE PERFORMANCE OR PATIENT RISK. THE AWARENESS DATE CORRESPONDS TO WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT DETAILS. ALL INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THIS TIME HAS BEEN INCLUDED. THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

Description of Event or Problem

THE CUSTOMER REPORTS DURING A TRANSHEPATIC ARTERY CHEMOEMBOLIZATION, THE SURGEON OPENED THE PACKAGE AND FOUND THAT THE MICROSPHERES INSIDE THE SYRINGE WERE NOT SOAKED IN PHYSIOLOGICAL SALINE SOLUTION, AND ONLY DRY POWDER MICROSPHERES REMAINED IN THE SYRINGE. NO ADDITIONAL INFORMATION WAS PROVIDED.