ACIST

Additional Manufacturer Narrative

ALTHOUGH REQUESTED, THE CINE-ANGIOGRAMS OF THE EVENT WERE NOT RETURNED FOR EVALUATION.THIS REPORT IS CLOSED.

Additional Manufacturer Narrative

A2: NO PATIENT INFORMATION. PATIENT AGE IS AN ESTIMATE. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(6), WAS RETURNED TO ACIST ON (B)(6) 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. IT WAS REPORTED THAT THE USERS USED A NON-ACIST HAND CONTROLLER KIT, WHICH INCLUDES HIGH-PRESSURE TUBING AND STOPCOCK. THE ACIST CVI® CONTRAST DELIVERY SYSTEM USER'S GUIDE, PG. 21, STATES THE FOLLOWING: THE SYSTEM IS TO BE USED ONLY WITH ACIST-PROVIDED CONSUMABLE KITS, AND ONLY THOSE KITS THAT ARE INTENDED FOR USE WITH THE CVI SYSTEM. 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 HAVE BEEN REQUESTED TO BE RETURNED FOR EVALUATION. UPON RETURN OF THE CINE-ANGIOGRAMS, THE CLINICAL EVALUATION SUMMARY WILL BE PROVIDED IN A FOLLOW-UP REPORT.

Description of Event or Problem

DURING A CORONARY ANGIOGRAPHY, THE CVI INJECTOR AND CONSUMABLES WERE PREPARED AS USUAL PRIOR TO THE PROCEDURE WITHOUT ANY ALARM MESSAGES. AT THE START OF THE PATIENT PROCEDURE, AN IMPLAUSIBLE PRESSURE CURVE WAS OBSERVED (22/10), WHICH IS WHY THE USERS CHECKED THE PRESSURE TRANSDUCER SEVERAL TIMES AND ALSO SWITCHED TO P2 FOR HEMODYNAMIC PRESSURE MONITORING, BUT WITHOUT SUCCESS. THE USERS REPLACED THE THREE-WAY STOPCOCK, AND THE PRESSURE CURVE RETURNED TO NORMAL, BUT THEN THERE WAS A SUSPECTED AIR INJECTION TO THE PATIENT. THE PATIENT EXPERIENCED ST ELEVATION IN THE ECG, BUT THE PATIENT REMAINED STABLE. THE THREE-WAY STOPCOCK WAS REPLACED AGAIN AT THE CARDIOLOGIST'S REQUEST, AND THE PROCEDURE WAS CONTINUED. AFTER VISUALIZATION OF THE RIGHT CORONARY ARTERY (RCA), THERE WAS A SUSPECTED AIR INJECTION AGAIN, WHEREUPON THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE. THE PATIENT WAS STABILIZED WITH EPHEDRINE AND PRESSURE INFUSION, AND REPLACEMENT OF THE ACIST BT2000 MANIFOLD KIT.