MAUDE Adverse Event Report: Terumo Corporation, Ashitaka RUNTHROUGH; WIRE, GUIDE, CATHETER

Model Number	25-1011
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	06/22/2026
Type of Reportable Event	Death
Event or Problem Description
Terumo received the following information: it was reported that during percutaneous coronary intervention (pci) the wire upon removal became entrapped by the stent placed in the distal left anterior descending artery (lad) and was frayed.A portion of wire remained entrapped in the patient.There was no blood loss.Terumo medical corporation received an fda medwatch report on (b)(6) 2026.The event description states: "patient had heart failure, and had an impella placed in operating room prior to planned coronary angiogram for high risk cornary artery disease.In the cardiac cath lab, during angiogram, the runthrough 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." additional information was received on 30jun2026: the wire became entrapped in the distal edge of the distal edge of the stent and became uncoiled upon attempted removal snapping with the retained uncoiled distal stent, extending into the aorta.The wire was snared in the aorta and again further uncoiled and snapped again with the distal third of the coil in the artery.The vessel was very tortuous which may have contributed to wire ware.The procedure was high risk in a sick morbidly obese patient with reduced ejection fraction (ef) and severe comorbid conditions.Cause of mortality was likely multifactorial and related to poor ischemic reserve and intolerance to transient ischemia from percutaneous coronary intervention (pci).Clot did not form on the retained wire however the complication did prolong procedure time.Thus, unlikely the cause of death but a key contributor.Additional information was received on 02jul2026: the patient had an impella device implanted prior to procedure.The device was implanted on (b)(6) 2026 and explanted on (b)(6) 2026.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): Terumo Corporation, Ashitaka; 150 maimaigi-cho; fujinomiya, shizuoka 418-0 015; JA 418-0015
• MDR Report Key: 50036062
• Report Number: 50036062
• Device Sequence Number: 16067511
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)290131(10)260205
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 07/27/2026
• Report Date (Section F): 07/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25-1011
• Device Catalogue Number: TW*AS418XA
• Device Lot Number: 260205Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/29/2026
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7 Wires.; Additional information was received on 02Jul2026.; Onyx Frontier 3.0x30mm.; Stent.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 301 LB
• Date Report Sent to FDA: 07/27/2026