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

Model Number	25-3011
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the cath lab was performing a complex interventional procedure and had a terumo runthrough interventional wire fracture while in the patient's coronary artery.The physician attempted to snare and retrieve the fractured wire; however, it was unsuccessful.The wire remained in the patient's coronary artery and, per the physician, was sandwiched in between the outer stent struts and the coronary vessel wall.The procedure was completed successfully, and the patient was in good condition per the cardiologist.An rl was placed; however, the staff did not retain the fractured wire post procedure, and it was discarded by accident.The device stickers for the wire in question were placed on the charge sheet and the associated information was provided.The location of fractured wire was in the 1st diagonal.Five runthrough wires were opened and used for the procedure (b)(6).After speaking to the physicians, they believe this was not a product issue; however, a procedural complication due to the in the diagonal wire getting stuck on the lad stent during a dk crush.No blood loss was reported.There was no surgical intervention required.

• 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: 21642650
• Report Number: 2243441-2025-00011
• Device Sequence Number: 20721297
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)270630(10)240702
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/19/2025
• Report Date (Section F): 03/19/2025

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*AS418XA
• Device Lot Number: 240702Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/27/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/19/2025