MalfunctionKRD
MREYE
Received Mar 5, 2026 · Event occurred Feb 16, 2026
Report 24518255 · MDR key 24518255
Device
Generic name
Device, Vascular, For Promoting Embolization
Manufacturer
Cook Medical LlcLot number
15744715
Patient
35 MO · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS NO COIL IN THE DELIVERY SYSTEM. IT WAS EMPTY. THE CATHETER THAT WAS INTENDED TO DELIVER A COIL DURING THE PROCEDURE WAS INSERTED INTO THE BODY AND POSITIONED IN PREPARATION OF COIL DEPLOYMENT, BUT THE COIL WAS ABSENT. THE DEVOID CATHETER WAS REMOVED AND A NEW CATHETER/COIL WAS SUCCESSFULLY OBTAINED AND USED. THE COIL WAS BEING DEPLOYED AS PART OF THE SCHEDULED PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.