ACIST

Additional Manufacturer Narrative

ON NOVEMBER 16, 2025, THE ACIST MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING ASSESSMENT AFTER REVIEW OF THE INFORMATION REPORTED BY THE USER FACILITY: IT APPEARS THAT THE OBSERVED AIR INJECTION INTO THE RIGHT CORONARY ARTERY (RCA) WAS TEMPORALLY RELATED TO THE OBSERVATION OF THE PATIENT BECOMING UNRESPONSIVE. HOWEVER, THERE WAS NO INFORMATION PROVIDED ON THE AMOUNT OF AIR INJECTED AND WHETHER THERE WAS ANY CHANGE IN CARDIAC FUNCTION IN RESPONSE TO THE AIR INJECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, A FOLLOW-UP REPORT WILL BE PROVIDED TO THE FDA. THIS REPORT IS CLOSED.

Description of Event or Problem

DURING A LEFT HEART CATHETERIZATION (LHC) USING THE ACIST CVI CONTRAST INJECTION SYSTEM, THE RIGHT CORONARY ARTERY (RCA) WAS INJECTED WITH CONTRAST THAT SHOWED STENOSIS. SUBSEQUENT INJECTION OF CONTRAST WAS FOLLOWED BY AIR BUBBLES, CAUSING THE PATIENT TO BECOME UNRESPONSIVE. THE PATIENT HAD UNEQUAL PUPILS AND RIGHT-SIDE FLACCIDITY. A STROKE ALERT WAS CALLED WITH A CT SCAN OF THE HEAD PERFORMED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND THEN TO THE UNIVERSITY OF KENTUCKY HOSPITAL. THE PATIENT RECOVERED AFTER TRANSPORT.

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTOR, MODEL CVI, SERIAL NUMBER (B)(6), WAS RETURNED TO ACIST ON (B)(6) 2025. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR USE OF THE DEVICE. PER THE ACIST CVI USER'S MANUAL, THE AIR COLUMN DETECT SENSOR IS DESIGNED TO AID THE USER IN THE DETECTION OF AIR COLUMNS IN THE INJECTION LINE, BUT IT IS NOT DESIGNED TO REPLACE THE VIGILANCE AND CARE REQUIRED OF THE OPERATOR IN VISUALLY INSPECTING FOR AIR AND CLEARING AIR FROM THE ENTIRE PATIENT KIT AND ANGIOGRAPHIC CATHETER. THE AIR COLUMN DETECT MECHANISM IS TO BE USED IN CONJUNCTION WITH AND TO COMPLEMENT THE USER'S OTHER PROCEDURES FOR PREVENTING AIR INJECTIONS. IN ADDITION, SUPPORT PERSONNEL MUST ENSURE THAT: ALL SYSTEM CONNECTIONS ARE IN PLACE, SECURE, AND FUNCTIONAL. THE CINE-ANGIOGRAMS HAVE BEEN REQUESTED TO BE RETURNED FOR EVALUATION. UPON RETURN OF THE CINE-ANGIOGRAMS, THE CLINICAL EVALUATION SUMMARY WILL BE PROVIDED IN A FOLLOW-UP REPORT.