ACIST

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 NOT BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.

Description of Event or Problem

A 56 YEAR OLD MALE PATIENT WITH CHEST PAIN AND AN IRREGULAR ECG ARRIVED FROM THE EMERGENCY DEPARTMENT FOR URGENT CARDIAC CATHETERIZATION. DURING THE SECOND INJECTION, 6 CC OF AIR WAS INJECTED INTO THE PATIENT, AND MULTIPLE BLOOD CLOTS WERE SUBSEQUENTLY OBSERVED. THE PATIENT DEVELOPED RECURRENT CARDIAC ARREST REQUIRING FOUR RESUSCITATION EVENTS AND COULD NOT BE STABILIZED. INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT WAS INITIATED, AND THE PATIENT WAS TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT FOR CONTINUED MONITORING.

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS EVALUATED ON FEBRUARY 25, 2026. 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 FEBRUARY 28, 2026, THE ACIST MEDICAL ADVISORY BOARD (MAB) MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: THE AVAILABLE INFORMATION DESCRIBES AN URGENT ANGIOGRAM PERFORMED WHERE ON THE SECOND INJECTION, AIR WAS VISUALIZED IN THE CORONARY ARTERY. IT APPEARS THAT THE AIR INJECTION ITSELF WAS NOT SEEN. THE USER DESCRIBES A SIGNIFICANT CLOT VISUALIZED IN THE VESSEL. THE MAB MEMBER COULD NOT COMMENT ON THE LIKELIHOOD THAT AIR WAS INJECTED OR WHAT THE CAUSE OF SUCH INJECTION COULD BE WITHOUT MORE INFORMATION AND REVIEW OF THE CINE ANGIOGRAM IMAGES. IT IS APPARENT THAT THE PATIENT BECAME VERY ILL AND THE EVENT ITSELF WAS CLEARLY SIGNIFICANT. IN JANUARY, AFTER THE EVENT, ACIST'S DISTRIBUTOR IN ISRAEL PROVIDED CLINICAL TRAINING TO THE USERS. BASED ON THE EVALUATION OF THE TESTING AND EVALUATION OF THE CVI INJECTION SYSTEM, THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT. THIS REPORT IS CLOSED.