ACIST

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER: (B)(6), WAS RETURNED TO ACIST ON FEBRUARY 11, 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. IN ADDITION, SUPPORT PERSONNEL MUST ENSURE THAT: ALL SYSTEM CONNECTIONS ARE IN PLACE, SECURE, AND FUNCTIONAL. THE CINE-ANGIOGRAMS WERE NOT RETURNED FOR EVALUATION. THE CVI CONSUMABLE KITS ACIST SINGLE-USE MANIFOLD KIT, MODEL: BT2000, LOT: 14424M; ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL: AT-P54, LOT: 19124D, AND A2000 MULTI-USE SYRINGE KIT, LOT: 12024N, USED DURING THE EVENT WILL BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE COMPLETION OF THE CONSUMABLE EVALUATION.

Description of Event or Problem

DURING A CORONARY ANGIOGRAPHY USING THE ACIST CVI INJECTION SYSTEM, AFTER THE PATIENT TUBING WAS FLUSHED WITH SALINE AND IMMEDIATELY AFTER THE FIRST INJECTION OF CONTRAST, A LARGE BUT TRANSIENT AIR COLUMN WAS NOTICED WITHIN THE PATIENT VASCULATURE. THE PATIENT WAS RESUSCITATED IN THE CARDIAC CATHETERIZATION LAB ROOM AND REQUIRED PROLONGED HOSPITALIZATION.

Additional Manufacturer Narrative

THE CVI CONSUMABLE KITS ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 14424M; ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P54, LOT 19124D, AND A2000 MULTI-USE SYRINGE KIT, LOT 12024N, USED DURING THE EVENT WERE NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW OF THE CONSUMABLES INDICATED NO DEVIATIONS OR NON-CONFORMITIES RELATED TO THE ISSUE REPORTED WITH THE USE OF THESE DEVICES. THIS REPORT IS CLOSED.