ACIST
Received Jul 15, 2025 · Event occurred Jun 15, 2025
Report 2134243-2025-00012 · MDR key 22512245
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Acist Medical Systems, Inc.Model number
CVICatalog number
014657
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
71 YR · Unknown
- Air Embolism
- Air Embolism
Narrative
Additional Manufacturer Narrative
A2: NO PATIENT INFORMATION PROVIDED. THE PATIENT DATE OF BIRTH IS NOT KNOWN AND IS ESTIMATED. 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 A FOLLOW-UP REPORT.
Description of Event or Problem
DURING A CORONARY ANGIOGRAPHY, A STUDENT DOCTOR INJECTED AIR INTO THE PATIENT UPON THE LAST INJECTION OF CONTRAST MEDIA. THE PATIENT FLATLINED FOR 30 SECONDS, AFTER WHICH THE PATIENT BECAME RESPONSIVE AND WAS AWARE. ACCORDING TO THE USER FACILITY, THE AIR INJECTION WAS DUE TO USER ERROR. THE USER FACILITY REPORTED THAT THEY HAVE A CINE-ANGIOGRAM OF THE PROCEDURE THEY WILL EMAIL TO ACIST.