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.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: director cath lab.The actual device was not returned.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report from other facilities was found in the past.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual device was not returned and investigation of it could not be performed, it was not possible to clarify the cause of occurrence.Ashitaka factory has been making efforts in maintaining the quality of the product by performing following work and inspections.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly in the appearance.The outer diameter of product is controlled to confirm that there is no anomaly in it.The length of outer layer at the distal end is measured to confirm that there is no missing part.The instructions for use (ifu) of this product includes the following warning: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel." terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.For the importer report refer to section h10.

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22904834
• Report Number: 9681834-2025-00159
• Device Sequence Number: 7932832
• 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
• PMA/510(K) Number: K063372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown