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

Model Number	GR3509
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: the glidewire tip fractured on plaque inside the patient's superficial femoral artery (sfa).The entire wire was successfully removed.There was no blood loss, and the patient was stable.Additional information was received on 12jan2026: the procedure performed was a peripheral revasc of the sfa.The wire was removed, and a snare was used to pull the tip out.An angiogram was performed to confirm the tip was removed entirely.The patient was stable following the removal of the wire.

• 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: 24212170
• Report Number: 2243441-2026-00001
• Device Sequence Number: 13175147
• Product Code: DQX
• UDI-Device Identifier: 04987350773210
• UDI-Public: (01)04987350773210(17)270331(10)250412
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/29/2026
• Report Date (Section F): 01/29/2026

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: GR3509
• Device Catalogue Number: RF*GA35263A
• Device Lot Number: 250412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2026
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/29/2026