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
Additional Manufacturer Narrative
A4: weight: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: heart and vascular lab manager.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.Since the actual device was not returned, investigation of it could not be performed.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.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 identify the cause of occurrence.(countermeasure) ashitaka factory assures the quality of this product by performing following controls.The outer diameter of wire is controlled to assure its strength.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as a kink or scratch.The ifu of this product includes the following warning.If any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire m and/or the catheter and determine the cause by fluoroscopy.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 ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).Please refer to section h10 for the importer's report on the reported event.
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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22487944
• Report Number: 9681834-2025-00125
• Device Sequence Number: 8016505
• 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
• PMA/510(K) Number: K863138
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: .018 COMMAND; .018 CXI CROSSING CATHETER; .018 GLIDEWIRE GOLD; 4 X 90 COOK LONG SHEATH; 5FR PINNACLE; ARMANDA; SHOCKWAVE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic