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

Model Number	GAT1830
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.History investigation of the product with the involved product code/lot number - 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.Cause of occurrence 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.Countermeasure ashitaka factory has been making efforts to maintain the quality of the product by performing the following work and inspections.- before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly in appearance.- the outer diameter of product is controlled to confirm that there is no anomaly in it.- as a pre-shipment inspection, slidability test is performed on sampling basis for each lot.The ifu of the 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.(b)(4) is submitting this report on behalf of (b)(6) factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that during a vascular surgery procedure, a crosstella balloon fractured (separated) from the shaft and had to be surgically removed.It was being used in conjunction with a glidewire advantage track.018 wire.The type of procedure performed was a peripheral artery revascularization.The reported event resulted in patient injury and/or required medical or surgical intervention.Additional information was received on 18jun2025: the patient is currently in the hospital.

• Brand Name: GLIDEWIRE ADVANTAGE TRACK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22432653
• Report Number: 9681834-2025-00120
• Device Sequence Number: 4631589
• Product Code: DQX
• UDI-Device Identifier: 04987350727848
• UDI-Public: (01)04987350727848(17)261031(10)241122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: GAT1830
• Device Lot Number: 241122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DESTINATION SLENDER; FIELDER WIRE; MEDTRONIC FMD WIRE
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Race: Black Or African American