ACIST

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON APRIL 8, 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.

Description of Event or Problem

DURING A CARDIAC CATHETERIZATION FOR A PATIENT PRESENTING WITH CHEST PAIN, SIX MINUTES AFTER THE START OF THE PROCEDURE, AIR WAS INJECTED INTO THE PATIENT'S RIGHT CORONARY ARTERY (RCA). THE PATIENT EXPERIENCED HYPOTENSION AND VENTRICULAR FIBRILLATION. THE PATIENT WAS STABLE AFTER DEFIBRILLATION PERFORMED.

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL: CVI, SERIAL NUMBER: (B)(6) WAS REQUESTED BY ACIST BUT 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. THE ACIST MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: THE REPORT DESCRIBES AN AIR INJECTION IN THE RIGHT CORONARY ARTERY, FOLLOWED BY VENTRICULAR FIBRILLATION THAT RESPONDED TO DEFIBRILLATION SHOCK. IT IS DIFFICULT TO DRAW FURTHER CONCLUSIONS BASED ON THE REPORT ALONE. ALTHOUGH THE INJECTION WAS MIDWAY THROUGH THE CASE, IT WAS AN INJECTION IN THE RIGHT CORONARY ARTERY (RCA). SO, IT IS POSSIBLE THAT THIS WAS THE FIRST INJECTION THROUGH THE RCA CATHETER, WHICH INCREASES THE LIKELIHOOD THAT THE AIR CAME FROM INCOMPLETELY EVACUATED AIR OF THE CATHETER OR TUBING/TUOHY. THE AMOUNT OF AIR INJECTED IS ALSO NOT DESCRIBED. IF ONLY A SINGLE BUBBLE WAS INJECTED, THIS IS LESS LIKELY TO BE THE CAUSE OF THE VENTRICULAR FIBRILLATION. IF THE CINE-ANGIOGRAMS BECOME AVAILABLE, FURTHER MEDICAL ASSESSMENT WILL BE PROVIDED. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.