ACIST

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 MAY 21, 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.

Description of Event or Problem

DURING A DIAGNOSTIC CORONOGRAPHY FOR RECURRENT CHEST PAIN ON AN 88-YEAR OLD FEMALE, AN AIR INJECTION OCCURRED. THE USER PREPARED THE CVI INJECTOR SYSTEM AND PURGED THE AIR, THEN PLACED ANOTHER MANUFACTURER'S "TIGER" DIAGNOSTIC DEVICE INTO THE AORTA. AN INJECTION OF CONTRAST WAS COMPLETED TO LOCATE THE LEFT CORONARY ARTERY (LCA) AND THEN SUBSEQUENTLY, A FULL INJECTION OF CONTRAST WAS COMPLETED INTO THE LCA, WITH NO VISIBLE AIR OBSERVED, AND THE PATIENT STARTED TO EXPERIENCE ST SEGMENT ELEVATION. THE USERS CHECKED THE RIGHT CORONARY ARTERY (RCA) AND SAW AN AIR BUBBLE BLOCKING THE RIGHT ARTERY. AFTER THE CHEST PAIN WAS CALMED (NO HEART ASSISTANCE) AND AFTER THE AIR BUBBLE WAS EVALUATED AND CONTROLLED, THE PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED HYPOTENSION AND ABNORMAL HEART RHYTHM\BRADYCARDIA AND WAS GIVEN ATROPINE TO TREAT. THE PATIENT RECOVERED THE SAME DAY.

Additional Manufacturer Narrative

ACIST'S MEDICAL ADVISOR REVIEWED THE INFORMATION PROVIDED BY THE USER FACILITY AND THIS ASSESSMENT IS AS FOLLOWS: THE REPORT FROM THE USER FACILITY DESCRIBES AN AIR INJECTION THAT WAS FOUND IN THE RCA (RIGHT CORONARY ARTERY), FOLLOWING INITIAL FLUSHING OF CATHETER TO INJECT THE LCA (LEFT CORONARY ARTERY). ALTHOUGH IT SOUNDS LIKE THE USER DID APPROPRIATE SET-UP OF THE DEVICE, IN THIS SITUATION THE HIGH LIKELIHOOD IS THAT THE CATHETER, TUOHY OR CONNECTORS WERE NOT COMPLETELY CLEARED OF AIR PRIOR TO THE FIRST "PUFF" INJECTIONS OF CONTRAST TO ALLOW CANNULATION OF THE LEFT MAIN ARTERY. IT IS VERY LIKELY THAT SOME OF THAT INCOMPLETELY EVACUATED AIR WAS INJECTED INTO THE AORTA AS THEY FILLED THE CATHETER AND LOCATED THE LEFT MAIN. SOME OF THAT AIR FLOWED TO THE RCA AND WAS SUBSEQUENTLY IDENTIFIED AND MANAGED APPROPRIATELY. THIS REPORT IS CLOSED.