ACIST

Description of Event or Problem

DURING A CORONARY ANGIOGRAPHY, AFTER THE USER COMPLETED A FULL FLUSH OF THE CONSUMABLE TUBING AND CATHETER, AND CONFIRMED THAT THE SYSTEM WAS FUNCTIONING PROPERLY, THE FIRST CONTRAST MEDIA INJECTION WAS COMPLETED WITHOUT ANY ISSUES. DURING THE SECOND INJECTION OF CONTRAST MEDIA, APPROXIMATELY 6 CUBIC CENTIMETERS OF AIR WAS INJECTED INTO THE PATIENT. AIR BUBBLES WERE OBSERVED IN THE PATIENT'S LEFT CORONARY SIDE DURING THE INJECTION. THE PATIENT EXPIRED ON (B)(6) 2025.

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.

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON (B)(6) 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. AFTER THE EVENT, THE TECHNICAL SERVICE MANAGER AND A SALES REPRESENTATIVE OF ACIST'S DISTRIBUTOR IN ISRAEL, VISITED THE HOSPITAL AND MET WITH THE HEAD NURSE AND THE HEAD OF DEPARTMENT TO REVIEW THE EVENT. ON (B)(6) 2026, THE ACIST MEDICAL ADVISORY BOARD MEMBER REVIEWED THE CINE-ANGIOGRAMS AND PROVIDED THE FOLLOWING ASSESSMENT: THE INFORMATION PROVIDED BY THE USER FACILITY REPORTS THAT AN AIR INJECTION OCCURRED AFTER SET UP OF THE CVI INJECTOR AND CONSUMABLES AND FOLLOWING INITIALLY NORMAL PROCEDURE. THE FILM ON DISC (CINE-ANGIOGRAMS) INITIALLY SHOWS AN ANGIOGRAM OF THE RIGHT CORONARY ARTERY (RCA). THERE ARE FOUR RUNS. THOSE APPEAR UNREMARKABLE WITHOUT EVIDENCE OF AIR INJECTED. THE SUBSEQUENT IMAGE SHOWS AN ANGIO OF THE LEFT CORONARY ARTERIES. THIS IS WITH A DIFFERENT CATHETER. THE INITIAL ANGIO OF THE LEFT CORONARY ARTERIES SHOWS A SINGLE BUBBLE INJECTED INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE NEXT ANGIO SHOWS AIR THAT IS INJECTED INTO BOTH THE LAD AND CIRCUMFLEX. ON BOTH IMAGES THE DYE (AND AIR) CLEAR QUICKLY. THE FINAL ANGIO RUN IS ALSO OF THE LEFT CORONARY ARTERIES AND SHOWS NORMAL CORONARY FLOW WITHOUT FURTHER AIR INJECTION. BASED ON TESTING AND EVALUATION OF THE CVI INJECTOR, THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE EVENT. THE CAUSE OF THE AIR INJECTION MAY HAVE BEEN DUE TO INCOMPLETE CLEARING OF AIR FROM THE HIGH-PRESSURE TUBING AND CATHETER (OUTSIDE THE AREA OF CONTROL OF THE AIR COLUMN DETECT SENSOR) BY THE USER WHEN THE CATHETERS WERE EXCHANGED, BUT THIS IS INCONCLUSIVE. THIS REPORT IS CLOSED.