STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTOR (SERIAL NUMBER (B)(6)) WAS COMPLETED ON NOVEMBER 10, 2025 WHICH CONFIRMED THAT THE EQUIPMENT WAS PERFORMING TO BAYER SPECIFICATION. THE STELLANT DISPOSABLE SET THAT WAS IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN ACCEPTED BY THE CUSTOMER AND WILL BE SCHEDULED. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THE FOLLOWING: (B)(6) YEAR OLD FEMALE PATIENT UNDERGOING A CONTRAST ENHANCED CT SCAN OF THE THORAX WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, APPROXIMATELY 9ML OF AIR WAS VISUALIZED WITHIN THE PATIENT'S NECK ON THE DISPLAYED IMAGES. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT AND SUBSEQUENTLY UNDERWENT A PERCUTANEOUS INTRAVASCULAR ULTRASOUND GUIDED ASPIRATION OF THE VENOUS AIR. ONCE COMPLETED, THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED WITH NO FURTHER ISSUES REPORTED.