MAUDE Adverse Event Report: Terumo Corporation, Ashitaka GLIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GS3509
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo received the following information: it was reported that during a femoral angiogram procedure, the physician noted that a portion of the glidewire fractured.The broken wire fragment remained in the patient.Additional information received 15-sept-2026: the physician attempted to remove the fragment but was unsuccessful.The fragment did not migrate, and the physician opted to leave it in place.No patient injury was reported.The estimated blood loss during the procedure was 400 ml.The patient had above knee amputation related to poor outflow of bypass graft/intractable pain/non-ambulatory status on (b)(6) 2026.

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): Terumo Corporation, Ashitaka; 150 maimaigi-cho; fujinomiya, shizuoka 418-0 015; JA 418-0015
• MDR Report Key: 50934451
• Report Number: 2243441-2026-00048
• Device Sequence Number: 9597998
• Product Code: DQX
• UDI-Device Identifier: 04987350773210
• UDI-Public: (01)04987350773210(17)270630(10)250723
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: GS3509
• Device Catalogue Number: RF-GA35263A
• Device Lot Number: 250723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 134 LB
• Patient Race: White
• Date Report Sent to FDA: 09/29/2026