MAUDE Adverse Event Report: TORAY INDUSTRIES (AMERICA), INC. TORAYGUIDE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	TRG-25175
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Outpatient arrived to ep [electrophysiology] lab for planned afib/ aflutter [atrial fibrillation/atrial flutter] ablation.During transseptal access, toray guidewire was removed and noted to have tip broken.Md able to visualize broken tip lodged in septum under fluoroscopy.Consult to structural heart team.Wire left in place in septum.Additional procedure performed (amplatzer septal occluder device implant).

• Brand Name: TORAYGUIDE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TORAY INDUSTRIES (AMERICA), INC.; 1251 avenue of the americas; suite 930; new york NY 10020
• MDR Report Key: 22166853
• Report Number: 22166853
• Device Sequence Number: 7957950
• Product Code: DQX
• UDI-Device Identifier: 04960685200781
• UDI-Public: (01)04960685200781
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2025
• Report Date (Section F): 06/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRG-25175
• Device Catalogue Number: TRG-25175
• Device Lot Number: 241205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/03/2025