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

Model Number	GS3508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the physician was attempting to re-cannulate the patient's chronically occluded innominate veins.The physician was attempting to re-cannulate the right innominate via femoral venous access.When the physician was within the occlusion, using the stiff angled glidewire, he pulled back on the wire, and approximately 40mm of the tip of the wire broke off into the occlusion.The physician did not attempt to retrieve the tip of the wire, as he believed he would not be successful in the re-cannulization, and the wire was completely within the occluded segment and would not be harmful to the patient.He then attempted to recanalize the left innominate vein and was successful.A stent was placed from the left innominate into the superior vena cava (svc), crossing the right innominate where the wire was.The patient remained stable throughout and the procedure was a success.The procedure was a superior vena cava recan.There was no blood loss.Additional information was received on 06aug2025: the broken wire was left in the patient, and no attempt was made to retrieve it.

• Brand Name: GLIDEWIRE
• 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: 22931752
• Report Number: 2243441-2025-00045
• Device Sequence Number: 10390054
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: (01)04987350773630(17)261031(10)241114
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2025
• Report Date (Section F): 09/01/2025

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 Model Number: GS3508
• Device Catalogue Number: RF*PA35183A
• Device Lot Number: 241114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2025
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/01/2025