ACIST

Description of Event or Problem

APPROXIMATELY 90 MINUTES AFTER A CORONARY ANGIOGRAPHY COMPLETED USING THE ACIST CVI INJECTION SYSTEM, A PATIENT COMPLAINED OF BLURRED VISION WITH FLOATERS AND LEFT FACIAL NUMBNESS. A CODE STROKE WAS CALLED AND AFTER NEUROLOGY EVALUATION, TENECTEPLASE (TNK) WAS ADMINISTERED TO THE PATIENT. THE CT SCAN SHOWED NO ACUTE BLEED OR ISCHEMIC CHANGES. THE FACILITY WANTS THIS CVI INJECTION SYSTEM EVALUATED BY ACIST EVEN THOUGH IT MAY BE UNRELATED TO THE EVENT.

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(6) HAS NOT YET BEEN RETURNED TO ACIST. THE CONSUMABLES USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE NOT KNOWN. THE CINE-ANGIOGRAMS HAVE BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON SEPTEMBER 17, 2025. 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. ON OCTOBER 10, 2025, THE ACIST MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING ASSESSMENT AFTER REVIEW OF THE CINES OF THE EVENT PROVIDED BY THE USER FACILITY: THE IMAGES SHOW A DIAGNOSTIC CORONARY ANGIOGRAM. THIS INCLUDES ANGIO RUNS OF THE RIGHT CORONARY ARTERY (RCA) AND THEN THE LEFT CIRCULATION. THE ANGIOGRAM DEMONSTRATES NORMAL APPEARING CORONARY ARTERIES. THERE IS NO ANGIOGRAPHIC EVIDENCE OF AIR INJECTION. THERE ARE NO APPARENT COMPLICATIONS. THE TIMING OF THE PATIENT'S SYMPTOMS (~90 MINUTES AFTER USE OF THE CVI INJECTOR), MAKES IT UNLIKELY THAT ANY THEORETICAL MALFUNCTION OF THE CVI INJECTOR CAUSED THE PATIENTS' SYMPTOMS.