CATHETER EXIMO ATHERECTOMY
Received Jun 10, 2026 · Event occurred Apr 29, 2026
Report 1319211-2026-10120 · MDR key 25461094
Device
Generic name
Catheter Eximo Atherectomy
Manufacturer
Eximo Medical Ltd.Model number
EXM-4003-H000Lot number
00131590
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AN END USER REPORTED AN ISSUE WITH AN AURYON ATHERECTOMY CATHETER 2.0MM - HYDROPHILIC COATED. IT WAS REPORTED THAT THE TIP DETACHED FROM THE END OF THE LASER; THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, AND THE PATIENT REMAINED UNAFFECTED. BASED ON ADDITIONAL INFORMATION FROM THE REP ON 12 MAY 2026, IT WAS NOTED THAT THE DISTAL OUTER TIP RING WAS LEFT BEHIND IN THE PATIENT, WHICH WILL RESULT IN SURGERY FOR THIS PATIENT.
Additional Manufacturer Narrative
THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).