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

Model Number	GR3508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received two fda medwatch reports # mw5175308.The event description states: "guide wire used in interventional radiology case is suspected to have left a wire fragment behind in patient resulting in retained foreign object.There are multiple guide wires used and it is impossible to know which one it was.The same thing happened to the same patient on a different interventional radiology case on july 11.Wire fragments were not removed because it is not in the best interest of the patient to remove at this time, we pulled the lots of wires involved in case it is needed and to make sure no patients received wires from those lots.".

• Brand Name: GLIDEWIRE
• 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: 23408968
• Report Number: 2243441-2025-00061
• Device Sequence Number: 8807041
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: (01)04987350773197(17)260831(10)240920
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/28/2025
• Report Date (Section F): 10/28/2025

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: GR3508
• Device Catalogue Number: RF*GA35183A
• Device Lot Number: 240820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/01/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• 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 Age: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/28/2025