MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDEWIRE ADVANTAGE TRACK; WIRE, GUIDE, CATHETER

Model Number	GAT1418
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that they had a deep vein thrombosis (dvt) procedure.They attempted to cross the cap of the lesion however, the wire got stuck in the webbing and broke off in the patient.The wire is in a stable position and will not need to be removed.There was no blood loss additional information was received on 26mar2025: the broken piece of the wire is approximately 1-3cm long.The patient was stable, and the procedure was successful.They do not want to try removing that part of the wire since it's in a safe, fibrotic location.

• Brand Name: GLIDEWIRE ADVANTAGE TRACK
• 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: 21885031
• Report Number: 2243441-2025-00016
• Device Sequence Number: 15501363
• Product Code: DQX
• UDI-Device Identifier: 04987350727862
• UDI-Public: (01)04987350727862(17)260831(10)240906
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2025
• Report Date (Section F): 04/22/2025

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 Expiration Date: 08/31/2026
• Device Model Number: GAT1418
• Device Lot Number: 240906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2025
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/22/2025