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

Model Number	GA1818
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the patient had a history of peripheral artery disease and was being treated in the cath lab for severe claudication.After performing initial angiogram, it showed the patient had a chronic total occlusion of the right popliteal artery.The physician attempted to cross the chronic total occlusion (cto) with the wire through a.018 cook cxi crossing catheter.The catheter and wire were advanced through sub intimal space.The wire was manipulated to reenter into true lumen, and they noticed the tip had broken off.The physician made multiple attempts to retrieve the tip of the wire with a snare; however, it was unsuccessful.After multiple attempts to recanalize the artery the physician was unsuccessful, and the case was aborted.There was no negative outcome for the patient post procedure.The procedure performed was a right lower extremity angiogram.Additional information was received on 13aug2025: there was no harm to the patient.

• Brand Name: GLIDEWIRE ADVANTAGE
• 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: 22904833
• Report Number: 2243441-2025-00046
• Device Sequence Number: 7932831
• Product Code: DQX
• UDI-Device Identifier: 04987350714749
• UDI-Public: (01)04987350714749(17)250930(10)231031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025
• Report Date (Section F): 08/27/2025

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: 09/30/2025
• Device Model Number: GA1818
• Device Catalogue Number: RA*FA18181C
• Device Lot Number: 231031A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2025
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/27/2025