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	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire was being used to go subintimal in an attempt to cross a calcified chronic total occlusion (cto) lesion.The tip got stuck and broke off in the lesion when pulled out.The procedure performed was a peripheral angioplasty.There was no blood loss and no patient injury.Additional information was received on 03jul2025: they left the piece in the patient, it was a calcified chronic total occlusion (cto) lesion so there was no harm to the patient, as there was already no flow in the vessel where the wire tip broke off.The wire fragment was approximately 1-2cm.

• 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: 22465613
• Report Number: 2243441-2025-00037
• Device Sequence Number: 4234877
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: (01)04987350773654(17)260531(10)240603
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/09/2025
• Report Date (Section F): 07/09/2025

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: 05/31/2026
• Device Model Number: GS3509
• Device Catalogue Number: RF*PA35263A
• Device Lot Number: 240603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2025
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 QUICKCROSS; 4FR ANGLED GLIDECATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/09/2025