ACIST

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON MARCH 17, 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

A2: NO PATIENT INFORMATION PROVIDED. THE PATIENT DATE OF BIRTH IS NOT KNOWN AND IS ESTIMATED. 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 WILL NOT BE RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.

Description of Event or Problem

DURING A LEFT HEART CATHETER CORONARY ANGIOGRAPHIC PROCEDURE, AIR WAS INTRODUCED INTO THE INJECTOR SYSTEM DESPITE ROUTINE PURGING AND FLUSHING AND INJECTED INTO THE PATIENT. IT IS UNKNOWN HOW MUCH AIR WAS INJECTED INTO THE PATIENT, BUT AN ENTIRE BOLUS OF CONTRAST WAS GIVEN. THE PATIENT EXPERIENCED CHEST PAIN FOR A DURATION OF SEVEN MINUTES, DIAPHORESIS, SEVERE BRADYCARDIA AND HYPOTENSION. THE STAFF WAS ABLE TO STABILIZE THE PATIENT WITH MEDICATION, AND THE PATIENT RECOVERED THE SAME DAY.