RUNTHROUGH
Received Jun 30, 2026 · Event occurred Jun 22, 2026
Report 25664207 · MDR key 25664207
Device
Generic name
Wire, Guide, Catheter
Manufacturer
Terumo CorpModel number
25-1011Catalog 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).