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

Model Number	GS3506
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the procedure was complicated by a fractured guidewire with the guidewire fragment lodged in a subintimal location along the left iliac artery.The attempts to snare and remove the fragment were not successful.Eventually, they decided that the safest thing for the patient was to leave the wire fragment in place.The fragment would have been secured by its subintimal location.The wire fragment was further secured with the deployment of adjacent balloon-expandable stents.The procedure was arterial angioplasty and atherectomy.No blood loss was reported.The reported event did not result in patient injury and/or require medical or surgical intervention.Additional information was received on 14jul2025: the size of fragment left in patient was 13 cm.Within a subintimal tract with tortuosity and resistance with torque applied to the wire using a torque device.The wire had been advanced through 5f kumpe and omni select catheters.The patient was in stable condition.There were no plans to remove wire fragments since they placed stents to secure.

• 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: 22578816
• Report Number: 2243441-2025-00039
• Device Sequence Number: 9237295
• Product Code: DQX
• UDI-Device Identifier: 04987350773593
• UDI-Public: (01)04987350773593(17)260930(10)241024
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/23/2025
• Report Date (Section F): 07/23/2025

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: GS3506
• Device Catalogue Number: RF*PA35153A
• Device Lot Number: 241024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/02/2025
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• 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; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/23/2025