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

Model Number	GM1813
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the physician was performing a right lower extremity angiogram with intervention.The physician gained access in the left common femoral artery, for up and over access to the right superficial femoral artery (sfa) and popliteal artery.Multiple attempts were made to cross a long segment chronic total occlusion (cto) lesion that began in the p1 segment of the popliteal artery and extended about halfway down into all of the tibial vessels.Retrograde tibial access was gained in both the distal anterior tibial artery as well as the distal posterior tibial artery with cook pedal access sheaths.A 0.018 90cm straight navicross and 0.018 glidewire gold were used to attempt to recannulate the posterior tibial artery into the popliteal.The physician was being fairly aggressive with trying to get thru the chronic total occlusion (cto), as the patient was not a vascular surgical candidate.Towards the very end of the procedure, it was noticed that the distal tip of the glidewire gold wire had broken off in the right lower extremity where the tibioperoneal trunk would have been.The length of the wire left was measured to be approximately 8-9mm.The physicians were not concerned about trying to retrieve the wire tip, as they believed it was extravascular and was within the area where the vessels were already occluded.No attempts were made to retrieve the wire piece and the physicians opened another glidewire gold wire to continue recanalization attempts.The physicians were unable to cross the chronic total occlusion (cto) lesion, so the case was not successful.The physicians stated that they did not believe the piece of wire left behind was problematic and no intervention was needed/required.The patient remained stable throughout and there was no injury to the patient due to the wire piece left behind.

• Brand Name: GUIDE WIRE M
• 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: 22406875
• Report Number: 2243441-2025-00033
• Device Sequence Number: 8293948
• Product Code: DQX
• UDI-Device Identifier: 04987350774231
• UDI-Public: (01)04987350774231(17)260430(10)240520
• 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): 07/04/2025
• Report Date (Section F): 07/04/2025

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: 04/30/2026
• Device Model Number: GM1813
• Device Catalogue Number: RF*RB18183TA
• Device Lot Number: 240520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/06/2025
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/04/2025
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/04/2025