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

Model Number	25-1011
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The medwatch event description stated that "the date of event is august 2025.The wire fractured in the coronary artery.Attempted removal of wire, approximately 10 mm of wire left in vessel.Patient had no chest pain and hemodynamically stable when procedure was completed.The procedure was a left heart catheterization." additional information was received on 08oct2025: all known information was reported to medsun.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 23359033
• Report Number: 2243441-2025-00055
• Device Sequence Number: 8888375
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)271231(10)250121
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025
• Report Date (Section F): 10/22/2025

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: 250121Y
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 10/22/2025