ACIST

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(6) WAS EVALUATED 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 CONSUMABLES USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN. THE CINE-ANGIOGRAMS WERE NOT RETURNED FOR EVALUATION. 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. UPON COMPLETION OF THE MEDICAL ADVISORY BOARD MEMBER'S CLINICAL EVALUATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.

Description of Event or Problem

DURING A CORONARY ANGIOGRAPHY ON AN 81-YEAR-OLD FEMALE FOR CARDIOGENIC SHOCK, ON THE FIRST INJECTION OF CONTRAST MEDIA INTO THE PATIENT, THERE WAS IATROGENIC AIR EMBOLISM IN THE ACUTE MARGINAL OF THE RIGHT CORONARY ARTERY. THE PATIENT EXPERIENCED HYPOTENSION.