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

Model Number	25-1011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the reported information.The doctor stated when he shaped the wire the tip feels like it breaks or was broken.The type of procedure was a left heart catheterization.There was no blood loss.Additional information was received on 27oct2025: the field clinical specialist (fcs) was present for the procedure on (b)(6) 2025.During the procedure, the doctor commented that the wire tip seemed broken when he went to shape it.There was no harm caused to the patient.The tip did not separate from the wire however it does feel like it was broken.When was shaped the wire instead of the tip replicating a nice curve, it seemed to kink or break at one point.Additional information was received on 31oct2025: the doctor stated that he has noticed this lately with the tip.

• 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: 23524147
• Report Number: 2243441-2025-00065
• Device Sequence Number: 21379161
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)280531(10)250610
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/11/2025
• Report Date (Section F): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 250610Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/23/2025
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/11/2025