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

Model Number	GM1831
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor had right groin access to intervene on a critical limb ischemia (cli).The pt vessel was occluded, the doctor tried to cross a heavy calcified lesion with a.018 command and did not cross, they then escalated to.018 glidewire gold.The glidewire gold entered into lesion however, it would not advance.The doctor removed the gm1831, however the distal tip detached and remained in the lesion.The remaining wire was removed.The doctor attempted to snare and retrieve the distal tip stuck in the occlusion via fem access and alternative distal access, however, was uneventful on each.The remaining distal tip of the gm1831 remained in the patient at the mid pt lesion.The event occurred prior to the terumo representative being in the room.The doctor did intervene elsewhere with shockwave, armada balloons, medtronic drug coated balloon (dcb) in the superficial femoral artery (sfa).They closed with a mynx.The patient will be monitored and did not go to surgery.There was no blood loss.Additional information was received on 17jun2025: the patient was in stable condition.They were going to watch and wait to see how foot wound heals; further intervention may be planned from there if needed, however, not at this time.

• 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: 22487943
• Report Number: 2243441-2025-00036
• Device Sequence Number: 18146699
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: (01)04987350711908(17)260731(10)240801
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025
• Report Date (Section F): 07/11/2025

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: 07/31/2026
• Device Model Number: GM1831
• Device Catalogue Number: RF*RA18303TA
• Device Lot Number: 240801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/16/2025
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• 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: .018 COMMAND; .018 CXI CROSSING CATHETER; .018 GLIDEWIRE GOLD; 4 X 90 COOK LONG SHEATH; 5FR PINNACLE; ARMADA; SHOCKWAVE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 07/11/2025