AURYON ATHERECTOMY CATHETER
Received Jun 23, 2026 · Event occurred May 31, 2026
Report 1319211-2026-10023 · MDR key 25598571
Device
Generic name
Catheter Eximo Atherectomy 2mm - Hydrophilic Coated
Manufacturer
Eximo Medical Ltd.Model number
EXM-4003-H000Lot number
00120468
Product problems
- Fracture
- Detachment of Device or Device Component
Patient
72 YR · Female
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).
Description of Event or Problem
AURYON CASE WITH 2.0MM FOR ANTERIOR TIBIAL AND TIBIAL TRUNK. 1ST LASER AURYON DONE PERFECTLY ON TIBIAL TRUNK. AFTER FINISH 1ST PROCEDURE, DOCTOR TAKE OUT THE CATHETER FOR POBA AND HE SAW THAT THE HEAD OF TIP CATHETER WAS GONE AND BURN. TIP OF CATHETER LEFT ON ARTERY AND FINALLY DOCTOR DECIDED TO TAKE OUT THE TIP WITH BALLON CATHETER 1.5MM AND THE TIP WAS OUT FROM ARTERY. 1ST PROCEDURE WAS DONE FOR 6 MINUTES. 2ND PROCEDURE FOR ANTERIOR TIBIAL CANCELED BY AURYON AND DOCTOR DECIDED BY DOING DEB ONLY.