ACIST

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON FEBRUARY 4, 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. THIS REPORT IS CLOSED.

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), HAS NOT YET BEEN RETURNED TO ACIST. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN. THE CINE-ANGIOGRAMS HAVE BEEN REQUESTED FOR EVALUATION BUT HAVE NOT YET BEEN RETURNED TO ACIST. A CLINICAL ASSESSMENT BY AN ACIST MEDICAL ADVISORY BOARD MEMBER WILL BE PERFORMED ON THE CINE-ANGIOGRAMS UPON RECEIPT. A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

DURING A PERCUTANEOUS CORONARY INTERVENTION USING THE ACIST CVI INJECTION SYSTEM, AIR WAS INJECTED INTO A PATIENT. THE AIR INJECTION OCCURRED AFTER INSERTION OF A CORONARY GUIDING CATHETER AND ENGAGEMENT INTO THE LEFT MAIN CORONARY ARTERY AND UPON INJECTION OF CONTRAST MEDIA. THE PATIENT EXPERIENCED CARDIOGENIC CRASH AND SHOCK AND EXPIRED THE SAME DAY.