inforMED
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 Llc

Lot 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.