MEDRAD® CENTARGO CT INJECTOR SYSTEM

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS NOTIFIED OF AN ALLEGED AIR EMBOLISM THAT OCCURRED ON (B)(6) 2026, INVOLVING A 54-YEAR-OLD FEMALE PATIENT DURING A CORONARY CTA PROCEDURE PERFORMED USING A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). POST-CONTRAST IMAGING REPORTEDLY DEMONSTRATED A LARGE VOLUME OF AIR WITHIN THE PULMONARY ARTERY, WITH AN ESTIMATED VOLUME OF APPROXIMATELY 20 ML. THE PATIENT WAS TREATED IN THE EMERGENCY DEPARTMENT, SUBSEQUENTLY STABILIZED, AND DISCHARGED FROM THE HOSPITAL. THE SITE HAS DISCONTINUED USE OF THE CENTARGO INJECTOR AT THIS TIME.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)) WAS COMPLETED ON (B)(6) 2026, CONFIRMING THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.