STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)) WAS COMPLETED ON (B)(6) 2026 AND CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MEDRAD® STELLANT DISPOSABLE SET USED DURING THE PROCEDURE WAS DISCARDED BY THE SITE AND WAS THEREFORE UNAVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES IN USE AT THE TIME OF THE INCIDENT; CONSEQUENTLY, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE CUSTOMER ALSO DECLINED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. THE SITE CONTINUES TO USE THE MEDRAD® STELLANT CT INJECTION SYSTEM AFTER THE REPORTED EVENT, WITH NO FURTHER ISSUES REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE MEDRAD® STELLANT INJECTOR SYSTEM WAS MANUFACTURED IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS, WITH NO IDENTIFIED DEVIATIONS, NONCONFORMANCES, FAILURES, OR QUALITY-RELATED ISSUES. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: VESSEL HAZARD - SERIOUS PATIENT INJURY MAY RESULT. FOLLOW INSTITUTIONAL EXTRAVASATION MINIMIZING TECHNIQUES. A SMALL VOLUME TEST INJECTION MAY BE UTILIZED TO CONFIRM VENOUS ACCESS. IT IS RECOMMENDED THAT THE OPERATOR STAY BY THE PATIENT'S SIDE AT THE BEGINNING OF THE INJECTION AND TO INSTRUCT THE PATIENT TO COMMUNICATE IMMEDIATELY ANY PAIN OR CHANGE IN FEELING DURING THE INJECTION. CHECK FOR EXTRAVASATION OF CONTRAST OR SALINE DURING INJECTION. IF AN EXTRAVASATION IS DETECTED, STOP THE INJECTION AND REFER TO RESPECTIVE FACILITY POLICY REGARDING TREATMENT. 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

BAYER MEDICAL CARE WAS NOTIFIED OF THE FOLLOWING EVENT: A 47-YEAR-OLD PATIENT UNDERWENT A CT EXAMINATION OF THE ABDOMEN AND PELVIS WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). A 22-GAUGE INTRAVENOUS CATHETER WAS PLACED IN THE PATIENT'S LEFT WRIST, WHICH WAS NOTED TO BE A DIFFICULT INTRAVENOUS INSERTION. POST INJECTION, WHEN NO CONTRAST WAS OBSERVED IN THE ACQUIRED CT IMAGES, THE CUSTOMER REPORTED THAT APPROXIMATELY 100 ML OF FLUID EXTRAVASATED INTO THE PATIENT'S LEFT WRIST AREA. CONSEQUENTLY, THE PATIENT DEVELOPED COMPARTMENT SYNDROME AND LATER REQUIRED A SURGICAL FASCIOTOMY.