ACIST

Additional Manufacturer Narrative

A2: PATIENT AGE/INFORMATION UNKNOWN. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER: (B)(6), WAS EVALUATED BY ACIST ON FEBRUARY 23, 2026. 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 CINE-ANGIOGRAMS ARE RETURNED FOR EVALUATION.

Description of Event or Problem

DURING AN ANGIOGRAPHY USING THE CVI INJECTION SYSTEM, A LARGE AMOUNT OF AIR (SPECIFIC AMOUNT NOT PROVIDED) WAS INJECTED INTO THE PATIENT, RESULTING IN UNSPECIFIED HARM. IT WAS UNCLEAR TO THE USER(S) HOW THE AIR WAS INJECTED INTO THE PATIENT. THERE WAS NO INDICATION OF AIR IN THE TUBING FROM THE CVI INJECTION SYSTEM. THE CVI INJECTOR CONTINUED TO BE USED AFTER THE INCIDENT WITH NO FURTHER ISSUES.

Additional Manufacturer Narrative

ON (B)(6) 2026, THE ACIST MEDICAL ADVISORY BOARD (MAB) MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: THE MAB MEMBER REVIEWED THE INFORMATION (REPORT) PROVIDED BY THE USER FACILITY. NO FILMS WERE AVAILABLE FOR REVIEW. THE REPORT DESCRIBED A LARGE VOLUME OF AIR INJECTED INTO THE PATIENT'S CORONARIES, THAT THE USERS BELIEVED WAS DUE TO INADEQUATE PREPARATION OF THE CVI INJECTION SYSTEM AND CONSUMABLE KITS. THE MAB MEMBER COULD NOT COMMENT ON THE VALIDITY OF THAT ASSERTION. IT APPEARS THAT THE PATIENT HAD TROPONIN ELEVATION, BUT HAD NOT EXPERIENCED CARDIAC ARREST, AND LIKELY RECOVERED/IS RECOVERING FROM THE EVENT. THIS REPORT IS CLOSED.