ACIST

Description of Event or Problem

DURING A CORONARY ANGIOGRAPHY USING THE CVI INJECTION SYSTEM, AIR WAS INJECTED INTO THE PATIENT. THE PATIENT EXPERIENCED ST SEGMENT ELEVATION, CHEST PAIN, BRADYCARDIA, AND HYPOTENSION.

Additional Manufacturer Narrative

D4: THE CVI INJECTOR SYSTEM SUBJECT TO THIS MEDWATCH REPORT WAS COMMERCIALIZED BEFORE THE FDA 21 CFR 801.20 UDI COMPLIANCE DATE FOR CLASS 2 DEVICES ON SEPTEMBER 24TH, 2016. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS EVALUATED BY ACIST ON MARCH 5, 2025. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN. 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. IN ADDITION, SUPPORT PERSONNEL MUST ENSURE THAT: ALL SYSTEM CONNECTIONS ARE IN PLACE, SECURE, AND FUNCTIONAL. THE CINE-ANGIOGRAMS WERE NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE CINEANGIOGRAMS ARE RETURNED FOR EVALUATION. THIS REPORT IS CLOSED.