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

Model Number	25-1011
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received a report involving a wire malfunction during a percutaneous coronary intervention (pci) procedure.The rtns wire was positioned in a branch vessel.Upon removal, the wire began to fray, and a wire fracture occurred.The wire was not trapped behind a stent or any other obstruction.Most of the fractured wire was successfully snared and removed.The event occurred intra-operatively.The patient remained stable and recovered from the procedure.No blood loss was reported.Additional information received on 21 aug 2025: the issue became apparent under fluoroscopy while attempting to retract the wire.No testing was performed.A portion of the wire remains in the patient's left anterior descending (lad) artery.No further attempts will be made to retrieve the remaining wire.The sample is contaminated with blood and body fluid but is not contaminated with infectious agents or anti-cancer agents.

• 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: 23069843
• Report Number: 2243441-2025-00050
• Device Sequence Number: 15905713
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)280131(10)250211
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025
• Report Date (Section F): 09/16/2025

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: 250108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/18/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• 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: SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/16/2025