EMPOWER CTA
Received Jul 21, 2026 · Event occurred May 30, 2026
Report 2134243-2026-00013 · MDR key 25899264
Device
Generic name
Injector, Contrast Medium, Automatic
Manufacturer
Acist Medical Systems, Inc.Model number
EMPOWER CTACatalog number
012412
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR · Female
- Extravasation
- Compartment syndrome
Narrative
Description of Event or Problem
A PATIENT WAS TRANSFERRED FROM (B)(6) TO HOSPITAL PASTEUR FOR A CT CORONARY ANGIOGRAPHY. DURING AN INTRAVENOUS INJECTION OF CONTRAST MEDIA, USING THE EMPOWER CTA INJECTOR SYSTEM WITHOUT EXTRAVASATION DETECTION ACCESSORY, A CONTRAST EXTRAVASATION OF APPROXIMATELY 80 ML OCCURRED. THE PATIENT SCAN WAS ABORTED. INITIAL MANAGEMENT FOR THE PATIENT WAS CARRIED OUT ACCORDING TO THE ESTABLISHED PROTOCOL. THE PATIENT RETURNED TO (B)(6) SHOWING SIGNS OF CONTRAST EXTRAVASATION THAT PROGRESSIVELY WORSENED, EVOLVING INTO COMPARTMENT SYNDROME. THE PATIENT RECEIVED THE FOLLOWING TREATMENT: DRAINAGE OF A FOREARM HEMATOMA WAS PERFORMED, RESULTING IN DECOMPRESSION. THE PATIENT RECOVERED ON (B)(6) 2026. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION REPORTED.
Additional Manufacturer Narrative
INITIAL INFORMATION PROVIDED BY THE USER FACILITY STATE THAT THE PRE-EXISTING CONDITION OF THE PATIENT AND PATIENT ANATOMY, INCLUDING THE TRAINING OF THE USER, MAY HAVE CONTRIBUTED TO THE EXTRAVASATION EVENT. ADDITIONAL TRAINING ON THE USE OF THE EMPOWER CTA INJECTOR WAS PROVIDED TO THE USER FACILITY TEAM MEMBERS ON (B)(6) 2026. THERE WAS NO REPORT OF A DEVICE MALFUNCTION OF THE EMPOWER CTA INJECTION SYSTEM. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL PROVIDE A FOLLOW-UP REPORT.