STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

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.

Description of Event or Problem

BAYER MEDICAL CARE WAS NOTIFIED OF THE FOLLOWING EVENT: AN 89 YEAR OLD FEMALE EMERGENCY DEPARTMENT PATIENT UNDERWENT A CT EXAMINATION TO EVALUATE AN ANEURYSM CLIP WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTOR (SERIAL NUMBER 301392). CONTRAST MEDIA WAS ADMINISTERED WITHOUT INCIDENT. AFTER THE CT EXAM, THE PATIENT WAS TRANSPORTED BACK TO THE EMERGENCY DEPARTMENT AND EXHIBITED NO SYMPTOMS. AIR BUBBLES WERE NOTED ON THE ACQUIRED CT IMAGES. FURTHER CLINICAL EVALUATION LATER IDENTIFIED A PULMONARY EMBOLISM. A NON CONTRAST FOLLOW UP CT STUDY WAS SUBSEQUENTLY REQUESTED AND COMPLETED.

Description of Event or Problem

BAYER MEDICAL CARE WAS NOTIFIED OF THE FOLLOWING EVENT: AN (B)(6) FEMALE EMERGENCY DEPARTMENT PATIENT UNDERWENT A CT EXAMINATION TO EVALUATE AN ANEURYSM CLIP WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTOR (SERIAL NUMBER (B)(6)). CONTRAST MEDIA WAS ADMINISTERED WITHOUT INCIDENT. AFTER THE CT EXAM, THE PATIENT WAS TRANSPORTED BACK TO THE EMERGENCY DEPARTMENT AND EXHIBITED NO SYMPTOMS. AIR BUBBLES WERE NOTED ON THE ACQUIRED CT IMAGES. FURTHER CLINICAL EVALUATION LATER IDENTIFIED A PULMONARY EMBOLISM. A NON CONTRAST FOLLOW UP CT STUDY WAS SUBSEQUENTLY REQUESTED AND COMPLETED. ON MARCH 6, 2026, THE CUSTOMER PROVIDED BAYER WITH ADDITIONAL INFORMATION REGARDING THE INCIDENT, INDICATING THAT SUBSEQUENT CLINICAL EVALUATIONS REVEALED AIR EMBOLI, INCLUDING A 30 × 13 MM COLLECTION IN THE PULMONARY TRUNK AND A 9 × 16 MM COLLECTION IN THE RIGHT VENTRICLE. THE PATIENT'S CURRENT STATUS IS NOTED AS GOOD.

Additional Manufacturer Narrative

THE CUSTOMER HAS DECLINED BAYER'S OFFER FOR AN INJECTOR CHECKOUT. NO DISPOSABLES WERE SAVED FROM THE INCIDENT, AND THE STAFF INDICATED THAT NO ADDITIONAL APPLICATIONS TRAINING IS DESIRED. ALTHOUGH THE DISPOSABLES USED DURING THE EVENT WERE DISCARDED, THE CUSTOMER IDENTIFIED LOT #252120 OF THE MEDRAD® STELLANT MULTI PATIENT DISPOSABLE TUBING (SSS SPD 250). BAYER PRODUCT ANALYSIS EVALUATED A RETAINED SAMPLE FROM THIS LOT AND FOUND NO VISUAL OR FUNCTIONAL DEFECTS, CONFIRMING THAT THE DISPOSABLE SETS PERFORMED TO SPECIFICATION WITHOUT ISSUES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INJECTOR SYSTEM WAS MANUFACTURED IN ACCORDANCE WITH ESTABLISHED SPECIFICATIONS, WITH NO IDENTIFIED DEVIATIONS, NONCONFORMANCES, FAILURES, OR QUALITY-RELATED ISSUES. 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. THE MEDRAD® STELLANT MULTI-PATIENT DISPOSABLE TUBING (SSS SPD 250) CONTAINS THE FOLLOWING RELEVANT EXCERPTS: ENSURE AIR IS EXPELLED FROM SYRINGES. WHILE PRIMING, TAP THE CHECK VALVES ON THE PATIENT TUBE TO REMOVE AIR BUBBLES. (1) PRIME TUBING. (2) CONFIRM THAT AIR IS EXPELLED FROM THE TUBING. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.