ACIST
Received Jul 1, 2026 · Event occurred Jun 8, 2026
Report 2134243-2026-00012 · MDR key 25678201
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
Patient
74 YR · Female
- Air Embolism
Narrative
Description of Event or Problem
DURING AN ANGIOGRAPHY ON A 74-YEAR-OLD PATIENT WITH EXERTIONAL ANGINA, AN AIR EMBOLISM OCCURRED. THE PATIENT EXPERIENCED ST SEGMENT ELEVATION, CHEST PAIN, VENTRICULAR FIBRILLATION, SEVERE BRADYCARDIA, EVIDENCE OF MYOCARDIAL INFARCTION, HYPOTENSION, AND PROLONGED HOSPITALIZATION. THE PATIENT EXPERIENCED SOME NEUROLOGICAL DAMAGE. THE PATIENT RECOVERED (B)(6) 2026.
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 HAVE NOT BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.