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

Model Number	25-3011
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the distal wire tip separated away from the main body of the wire during a coronary intervention.As a bailout the physician chose to stent the wire up against the vessel wall.Outcome for the patient was satisfactory.No blood loss was reported.Additional information was received on 19feb2025: the patient's anatomy was particularly tortuous at the point of separation.An acute angle/takeoff from the proximal lad into the ostium of the circumflex.Stents were deployed in the circumflex, circumflex ostium, and proximal lad.It was noted that the stents covered the wire segment in question prior to wire removal.Approximately 3-4cm; additionally, the wire segment that separated, was the estimated length of the radiopaque marker.The wire was stented proximal, and ostium of circumflex and proximal lad.The patient was stable.The intended procedure was able to be completed.

• 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: 21536921
• Report Number: 2243441-2025-00007
• Device Sequence Number: 7735943
• Product Code: DQX
• UDI-Device Identifier: 04987350720986
• UDI-Public: (01)04987350720986(17)270831(10)240930
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/06/2025
• Report Date (Section F): 03/06/2025

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: 25-3011
• Device Catalogue Number: TW*DS418FH
• Device Lot Number: 240930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/17/2025
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• 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; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/06/2025