inforMED
DeathDQX

RUNTHROUGH

Received Jun 30, 2026 · Event occurred Jun 22, 2026

Report 25664207 · MDR key 25664207

Device

Generic name

Wire, Guide, Catheter

Manufacturer

Terumo Corp

Model number

25-1011

Catalog number

TW*AS418XA

Lot number

260205Y

Patient

44 YR · Female

  • Foreign Body In Patient
  • Unspecified Heart Problem

Narrative

Description of Event or Problem

PATIENT HAD HEART FAILURE, AND HAD AN IMPELLA PLACED IN OR PRIOR TO PLANNED CORONARY ANGIOGRAM FOR HIGH RISK CORONARY ARTERY DISEASE. IN THE CARDIAC CATH LAB, DURING ANGIOGRAM, THE RUN THROUGH WHITE WIRE, UPON REMOVAL, BECAME ENTRAPPED BY THE STENT PLACED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY AND WAS FRAYED. A PORTION OF THE WIRE REMAINED ENTRAPPED IN THE PATIENT. RETAINED WIRE WAS REMOVED FROM PATIENT. WIRE FRACTURE WITH RETAINED WIRE IN THE LM (LEFT MAIN CORONARY ARTERY) INTO LAD (LEFT ANTERIOR DESCENDING ARTERY), SOME OF THE WIRE ABLE TO BE SNARED WITH FILAMENT PROTRUDING STILL INTO THE AORTA. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, RUN THROUGH (PER SITE REPORTER).