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

Model Number	GA1830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: while the wire was being used in the procedure, the tip of the wire broke roughly 10cm from the distal tip.The physician said that he was in a heavily calcified vessel and was torquing the wire before it broke.A new wire was opened and the case was completed.No patient impact was reported.There was no blood loss.Additional information was received on 09feb2026: there was a fragment left in the patient's body.The fragments were left in the vessel as the patient will need bypass and the artery the tip broke off in is completely occluded.
Additional Manufacturer Narrative
This report is being sent as follow up #1 to correct sections f11 and f13 as they were incorrect in the initial report.

• 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: 24491724
• Report Number: 2243441-2026-00007
• Device Sequence Number: 14697428
• Product Code: DQX
• UDI-Device Identifier: 04987350714763
• UDI-Public: (01)04987350714763(17)270630(10)250710
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026
• Report Date (Section F): 03/02/2026

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 Model Number: GA1830
• Device Catalogue Number: RA*FA18301C
• Device Lot Number: 250710Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/02/2026
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/03/2026
• 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: 03/02/2026