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
Additional Manufacturer Narrative
A5: ethnicity: not provided due to hospital policy.A6: race: not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.Since the actual device was not returned, analysis of it could not be performed.No anomaly was found in the manufacturing record and the shipping inspection record.No similar event was found in the past complaint file.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual device was not returned and the investigation of it could not be performed, it was not possible to identify the cause of occurrence.Ashitaka factory assures the quality of this product by performing the following inspection and control.The outer diameter of the wire strand is controlled to assure the strength of wire strand.Before the product packaging process, 100% visual inspection is performed to ensure there is no anomaly such as peeling of the outer layer or abrasion in appearance.The instructions for use (ifu) has the following description: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel." please refer to section h10 for the related reports.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24212171
• Report Number: 9681834-2026-00006
• Device Sequence Number: 21246109
• 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
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown