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

Model Number	25-1011
Medical Device Problem Codes	Break (1069); Unintended Deflation (4061)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received the following information: the rt got jailed/stuck between stent and tissue during a left heart cath (lhc).The doctor tried ballooning over the wire to release; however, that did not work.The pulled on the rt wire and it broke wire off at junction point as well as stretched wire.The doctor called another surgeon and the patient sent to surgery to remove the wire; however, there were no details on the success or extent of the removal.No blood loss was reported.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION - ASHITAKA; 150 maimaigi-cho; fujinomiya-shi, shizuoka 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO MEDICAL CORPOTATION; 950 elkton blvd; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 25813186
• Report Number: 2243441-2026-00033
• Device Sequence Number: 21466391
• Product Code: DQX
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/14/2026
• Report Date (Section F): 07/14/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/19/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2026
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/14/2026