ACIST

Additional Manufacturer Narrative

A2: AGE IS AN ESTIMATE. NO PATIENT INFORMATION WAS RECEIVED. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(6) 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. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT. THE ACIST MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: NO ANGIO FILMS WERE AVAILABLE FOR REVIEW. THE INFORMATION PROVIDED BY THE USER FACILITY DESCRIBES A PRESUMED AIR INJECTION THAT WAS FELT TO HAVE OCCURRED SHORTLY BEFORE THE FIRST ANGIOGRAPHIC IMAGE WAS OBTAINED. PRESUMABLY, THE AIR INJECTION OCCURRED DURING CONTRAST INJECTION THAT WAS GIVEN TO FILL THE CATHETER AND CONFIRM ENGAGEMENT OF THE CATHETER IN THE LEFT MAIN. THE PATIENT SUFFERED A CARDIAC ARREST, SO OBVIOUSLY A SIGNIFICANT EVENT. THE LARGE MAJORITY OF EVENTS THAT OCCUR IN THIS MANNER ARE DUE TO INADEQUATE CLEARING OF AIR FROM THE SYSTEM, CATHETER, TOUHY OR CONNECTORS PRIOR TO FIRST INJECTION.

Description of Event or Problem

THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY. THE PROCEDURE WAS PERFORMED UNDER MODERATE SEDATION. A 6 FR RIGHT RADIAL ARTERY ACCESS WAS OBTAINED FOR CORONARY ANGIOGRAPHY. IV HEPARIN WAS ADMINISTERED. DURING THE ANGIOGRAPHY, UPON THE FIRST INJECTION OF CONTRAST MEDIA USING A 5 FR, JL4 DIAGNOSTIC CATHETER WITH THE CATHETER ENGAGED WITHIN THE PATIENT'S LEFT MAIN CORONARY ARTERY (LCA), AIR WAS INJECTED INTO THE PATIENT. HYPERACUTE T WAVES WERE NOTED. THE PATIENT CODED AND HAD TO BE RESUSCITATED.