ACIST

Description of Event or Problem

DURING A CORONARY ANGIOGRAPHY ON A 61-YEAR-OLD MALE PATIENT WITH ANGINA AND EXERTIONAL DYSPNEA, A CHAIN OF AIR BUBBLES WAS INJECTED INTO THE PATIENT. THE PATIENT EXPERIENCED TRANSIENT ST ELEVATION WITH CHEST PAIN BECAUSE THE AIR BLOCKED THE FLOW IN THE DIAGONAL ARTERY (DA) FOR A PROLONGED BUT NOT PERMANENT PERIOD OF TIME. THE PATIENT SUBSEQUENTLY RECOVERED.

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 DECEMBER 18, 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 (B)(6) 2026, THE ACIST MEDICAL ADVISORY BOARD MEMBER REVIEWED THE AVAILABLE INFORMATION AND PROVIDED THE FOLLOWING ASSESSMENT: THE INFORMATION PROVIDED BY THE USER FACILITY DESCRIBES THAT THE NURSE NOTED SOME AIR INJECTION. IT IS NOT CLEAR HOW MUCH AIR OR WHEN IN THE PROCEDURE THIS OCCURRED. ALTHOUGH NOT CLEARLY STATED, IT APPEARS THAT THE PATIENT DID EXPERIENCE CHEST PAIN, THAT ONE OF THE CORONARY ARTERIES WAS TEMPORARILY OCCLUDED, AND THAT THE PATIENT RECOVERED WITH RESOLUTION OF CHEST PAIN. THIS REPORT IS CLOSED.