ACIST

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS EVALUATED ON MARCH 9, 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 MARCH 23, 2026, THE ACIST MEDICAL ADVISORY BOARD (MAB) MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: THE REPORT PROVIDED BY THE USER FACILITY DESCRIBES AN AIR INJECTION THAT OCCLUDED THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE IS NO DESCRIPTION OF HOW THE PATIENT REACTED OTHER THAN THAT THE PATIENT EXPERIENCED CHEST PAIN. THE ANGIOGRAM SHOWS A PATIENT WITH A PREVIOUS STENT IN THE LAD. THERE ARE THREE TO FOUR INITIAL IMAGES SHOWING PATENT VESSELS AND NORMAL FLOW THROUGH PREVIOUS STENTS. SUBSEQUENT IMAGES SHOW OCCLUSION OF THE LAD IN THE REGION OF THE PREVIOUS STENT. APPROXIMATELY SIX MINUTES LATER, ANOTHER ANGIOGRAM SHOWS RETURN OF NORMAL FLOW IN THE LAD AND THROUGH THE STENT. IT IS NOT CLEAR FROM THE REPORT OR THE FILMS WHETHER ANY INTERVENTION WAS PERFORMED IN THOSE SIX MINUTES. THE ANGIOGRAPHIC IMAGES DO NOT SHOW AN EPISODE OF AIR INJECTION. CERTAINLY, IT IS POSSIBLE THAT AN AIR INJECTION OCCURRED DURING AN INJECTION THAT WAS NOT RECORDED. THERE IS NO EVIDENCE OF AIR IN OTHER VESSELS. DURING THE ANGIOGRAM FOLLOWING RESTORATION OF FLOW, THE FLOW IN THE LAD AS WELL AS THE OTHER VESSELS APPEAR NORMAL. IT IS UNUSUAL THAT AIR HAD ENTERED BETWEEN INJECTIONS. IT IS NOT KNOWN IF CATHETERS WERE EXCHANGED OR IF THE CONSUMABLE TUBING WAS DISCONNECTED PRIOR TO THE AIR INJECTION, BUT THERE IS NO OVERT EVIDENCE OF THIS IN THE REPORT OR THE FILMS. AFTER RESTORATION OF FLOW, SOME BALLOON ANGIOPLASTY IS PERFORMED TO THE LAD PROXIMAL TO THE ZONE OF OCCLUSION. FINALLY, THREE ANGIOGRAPHIC IMAGES OF THE RIGHT CORONARY ARTERY (RCA) ARE RECORDED AND ARE UNREMARKABLE. THIS REPORT IS CLOSED.

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 REQUESTED TO BE RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.

Description of Event or Problem

DURING AN ANGIOGRAPHY, AIR WAS INJECTED INTO A PATIENT'S CORONARY ARTERY, CAUSING A TOTAL OCCLUSION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT EXPERIENCED CHEST PAIN, ST SEGMENT CHANGES, ABNORMAL HEART RHYTHM, AND HYPOTENSION. THE PATIENT RECOVERED.