ACIST

Additional Manufacturer Narrative

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 WILL NOT BE RETURNED FOR EVALUATION. THE ACIST MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: THE DOCUMENTS DESCRIBE A PATIENT BROUGHT TO THE CATH LAB FOR MANAGEMENT OF A MI. ON THE FIRST INJECTION, A LARGE AMOUNT (5 - 7 ML) OF AIR WAS INJECTED INTO THE CORONARIES. THE USER FACILITY DESCRIBES THE "LVA" ALREADY BEING OCCLUDED - IT IS ASSUMED THIS MEANS THE LEFT ANTERIOR DESCENDING ARTERY (LAD). REGARDLESS, THIS VOLUME OF AIR INJECTED WILL GENERALLY CAUSE OBSTRUCTION OF FLOW TO MUCH OF THE LEFT CORONARY SYSTEM. NOT SURPRISINGLY, THE PATIENT SUFFERED CARDIAC ARREST AND REQUIRED RESUSCITATION EFFORTS. THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB TO HAVE CORONARY OBSTRUCTION TREATED AT A LATER TIME. SINCE THE PATIENT WAS BROUGHT TO THE LAB FOR MANAGEMENT OF AN MI (PRESUMABLY A ST SEGMENT ELEVATION MI [STEMI]), IT IS POSSIBLE THAT THE CARDIAC ARREST WAS DUE TO THE MI, RATHER THAN THE AIR INJECTION. HOWEVER, GIVEN THE TIMING AND THE VOLUME OF AIR INJECTED, IT IS ASSUMED THE AIR INJECTION WAS THE PRIMARY CAUSE OF THE ARREST. THE USER FACILITY INFORMATION DESCRIBES THIS AIR INJECTION OCCURRING ON THE FIRST ANGIO IMAGE. WHEN AIR IS INJECTED ON THE FIRST INJECTION, IT IS USUALLY DUE TO INADEQUATE CLEARING OF AIR FROM THE SYSTEM OR CATHETERS, RATHER THAN DEVICE MALFUNCTION. HOWEVER, THE LIMITED AMOUNT OF INFORMATION PROVIDED RESULTS IN SOME UNCERTAINTY REGARDING THIS CONCLUSION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.

Description of Event or Problem

DURING A CORONARY ANGIOGRAPHY USING THE CVI INJECTION SYSTEM, AIR WAS INJECTED INTO THE PATIENT. THE PATIENT ARRIVED WITH A MYOCARDIAL INFECTION (MI). THE PHYSICIAN PICKED THE RADIAL ARTERY AND PREPARED THE ACIST CVI INJECTION SYSTEM. THE PHYSICIAN THOUGHT HE HAD PURGED THE TUBING WITH CONTRAST MEDIA. A SECOND PHYSICIAN ARRIVED AS IT WAS A COMPLEX PATIENT, DID A SMALL CONTRAST MEDIA PURGE, THEN INJECTED CONTRAST MEDIA FULLY. A SIGNIFICANT AIR COLUMN WAS SENT AND BLOCKED THE LVA (CORONARY ARTERY WAS ALREADY BLOCKED BY INFARCTION). PATIENT'S HEART STOPPED AND PATIENT WAS RESUSCITATED FOR 25 - 30 MINUTES. PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU) AND WAS TREATED FOR MI SUCCESSFULLY. PATIENT WAS IN THE ICU FOR EIGHT DAYS TOTAL AND WAS DISCHARGED ON (B)(6) 2024. PATIENT WAS FOLLOWED UP ON FREQUENTLY AND HAD STABILIZED.

Additional Manufacturer Narrative

THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON MARCH 27, 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. THIS REPORT IS CLOSED.