MAUDE Adverse Event Report: TERUMO CORP RUNTHROUGH; WIRE, GUIDE, CATHETER

Model Number	25-1011
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Heart Problem (4454)
Date of Event	06/22/2026
Type of Reportable Event	Death
Event or Problem Description
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).

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORP; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 25664207
• Report Number: 25664207
• Device Sequence Number: 21444549
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)290131(10)260205Y
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026
• Report Date (Section F): 06/29/2026

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
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 137 KG
• Date Report Sent to FDA: 06/29/2026