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

Model Number	GA3501
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following information: it was reported that after the procedure when the glidewire was removed, the end of the wire appeared to have shredded, and part of the tip/plastic remained inside the patients groin area.They were able to remove the piece from the patient.Establishment vascular access femoral approach for endovascular stent insertion into abdominal aortic aneurysm was the procedure performed for the patient.

• Brand Name: GLIDEWIRE ADVANTAGE
• 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: 24606328
• Report Number: 2243441-2026-00009
• Device Sequence Number: 10372052
• Product Code: DQX
• UDI-Device Identifier: 04987350703620
• UDI-Public: (01)04987350703620(17)270930(10)251031
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/16/2026
• Report Date (Section F): 03/16/2026

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: GA3501
• Device Catalogue Number: RA*CA35185C
• Device Lot Number: 251031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/17/2026
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Date Report Sent to FDA: 03/16/2026