MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDEWIRE GT-R; WIRE, GUIDE, CATHETER

Model Number	GT*ES1618A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: during prostate artery embolization, the 016 gt-r was used with a 2.0 progreat microcatheter.While advancing the wire through the prostate artery the wire dissected the vessel, it was confirmed with angiogram.This caused the result of procedure to be an incomplete embolization.There was no blood loss, the patient left the room in stable condition.The procedure was an aortogram.

• Brand Name: GLIDEWIRE GT-R
• 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: 23998906
• Report Number: 2243441-2025-00073
• Device Sequence Number: 15998444
• Product Code: DQX
• UDI-Device Identifier: 04987350745408
• UDI-Public: (01)04987350745408(17)270430(10)250514
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/07/2026
• Report Date (Section F): 01/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: GT*ES1618A
• Device Catalogue Number: GT*ES1618A
• Device Lot Number: 250514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/10/2025
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/07/2026