InjuryMCW
AURYON ATHERECTOMY CATHETER
Received Jul 2, 2026 · Event occurred Jun 8, 2026
Report 1319211-2026-10028 · MDR key 25689556
Device
Generic name
Auryon Atherectomy Catheter 1.7mm - Hydrophilic Coated
Manufacturer
Eximo Medical Ltd.Model number
EXM-4012-H000Lot number
00122855
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Male
- Hemorrhage/Blood Loss/Bleeding
- Swelling/ Edema
Narrative
Description of Event or Problem
RIGHT GROIN DRESSING SATURATED POST ANGIOGRAM REQUIRING MANUAL PRESSURE AND VASCULAR SURGERY INTERVENTION FOR HEMOSTASIS WITH ASSOCIATED ECCHYMOSIS AND SWELLING.
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).