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

Model Number	GR3508
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire was severed during a neuro procedure inside the patient's internal jugular vein.The severed parts of the wire were successfully retrieved.There was no reported blood loss.The event occurred intra-operatively and did not result in patient injury or necessitate medical or surgical intervention.Additional information was received on 03 jun 2025: two severed pieces were snared.The patient is stable.A navicross, angled, was used with the glidewire.

• 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: 22375290
• Report Number: 2243441-2025-00034
• Device Sequence Number: 20855846
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: (01)04987350773197(17)260930(10)241028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025
• Report Date (Section F): 07/01/2025

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: 09/30/2026
• Device Model Number: GR3508
• Device Catalogue Number: RF*GA35183A
• Device Lot Number: 241028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/02/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/01/2025