RADIFOCUS GLIDEWIRE ADVANTAGE

Description of Event or Problem

ON (B)(6) 2026 AT APPROXIMATELY 10:15 AM, DURING A PERIPHERAL VASCULAR INTERVENTION (AORTOGRAM WITH RUNOFF VIA POPLITEAL APPROACH FOR 100% CHRONIC TOTAL OCCLUSION OF THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY) IN THE CARDIAC CATHETERIZATION LAB, A TERUMO RADIFOCUS GLIDEWIRE ADVANTAGE WAS BEING REMOVED FROM THE PATIENT'S VESSEL WHEN THE DISTAL TIP FRACTURED AND SEPARATED FROM THE WIRE BODY. THE RETAINED WIRE TIP IS LOCATED IN THE LEFT LEG, DISTAL SUPERFICIAL FEMORAL ARTERY, IN A SUBINTIMAL POSITION. THE FRAGMENT WAS NOT CAUSING ACUTE RISK FOR HARM AT THE TIME OF THE EVENT. NO INJURY TO THE PATIENT AT THE TIME OF THE EVENT. THE PATIENT WAS DISCHARGED THE SAME DAY WITH PLANS FOR FOLLOW-UP INTERVENTION IN APPROXIMATELY TWO WEEKS TO PLACE A STENT AT THE SITE OF THE RETAINED WIRE FRAGMENT. THE ATTENDING PHYSICIAN DISCUSSED THE EVENT, ACTIVITY MODIFICATIONS, AND WARNING SIGNS WITH THE PATIENT AND FAMILY PRIOR TO DISCHARGE. THE DEVICE AND ORIGINAL PACKAGING ARE RETAINED BY THE FACILITY RISK MANAGER AND AVAILABLE FOR EVALUATION. DEVICE WAS A SINGLE-USE DISPOSABLE GUIDEWIRE USED WITHIN ITS INDICATED PURPOSE. NO REUSE. NO ALARM APPLICABLE. WIRE WAS WITHIN ITS LABELED EXPIRATION DATE (07/2027). FRACTURE OCCURRED DURING ROUTINE REMOVAL, NOT DURING ADVANCEMENT OR NAVIGATION. PROXIMAL PORTION OF THE WIRE WAS SUCCESSFULLY REMOVED. THE OPERATOR WAS THE ATTENDING PHYSICIAN. THE FACILITY HAS QUARANTINED THE DEVICE (PROXIMAL PORTION) AND ORIGINAL PACKAGING FOR POTENTIAL EVALUATION.