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

Model Number	GS3506
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the procedure was complicated by a fractured guidewire with the guidewire fragment lodged in a subintimal location along the left iliac artery.The attempts to snare and remove the fragment were not successful.Eventually, they decided that the safest thing for the patient was to leave the wire fragment in place.The fragment would have been secured by its subintimal location.The wire fragment was further secured with the deployment of adjacent balloon-expandable stents.The procedure was arterial angioplasty and atherectomy.No blood loss was reported.The reported event did not result in patient injury and/or require medical or surgical intervention.Additional information was received on 14jul2025: the size of fragment left in patient was 13 cm.Within a subintimal tract with tortuosity and resistance with torque applied to the wire using a torque device.The wire had been advanced through 5f kumpe and omni select catheters.The patient was in stable condition.There were no plans to remove wire fragments since they placed stents to secure.
Additional Manufacturer Narrative
E3: occupation: clinical lead.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.Please refer to section h10 for the importer's report on the reported event.Terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Actual device upon receipt: only a guidewire main body.Microscopic inspection: the outer layer had been elongated, and a torn shape was found in the fractured section.No anomaly such as a scratch was found in other sections.Electron microscopic inspection of the wire: the outer layer of actual device was removed to confirm the condition of wire at the fractured section.No taper was found on the side surface of wire at the fractured section.Radial patterns were found on the top surface of wire at the fractured section.Confirmation of dimensions: outer diameter at the normal sections met the factory's specifications.No anomaly was found.Confirmation of the missing length - · guidewire main body: approximately 1365mm · current product: approximately 1501mm compared to the product with the involved product code, it was likely that there was a missing of approximately 116mm.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Simulation test: regarding the fracture on the guidewire, following simulation test was performed.Continuous torque force was applied in the same direction while the device was bent.No taper was found on the side surface of wire at the fractured section.Radial patterns were found on the top surface of wire at the fractured section.These conditions were likely to be similar to those of the actual device.Simulation test: regarding the fracture on the guidewire, following simulation test was performed.Continuous torque force was applied in the same direction while the device was bent.No taper was found on the side surface of wire at the fractured section.Radial patterns were found on the top surface of wire at the fractured section.These conditions were likely to be similar to those of the actual device.Ashitaka factory assures the quality of this product by performing following inspection and control.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 peeling of the outer layer, a scratch or kink.The instructions for use (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 glidewire 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.".

• 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
• 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: 22578595
• Report Number: 9681834-2025-00134
• Device Sequence Number: 9229499
• Product Code: DQX
• UDI-Device Identifier: 04987350773593
• UDI-Public: (01)04987350773593(17)260930(10)241024
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 09/30/2026
• Device Model Number: GS3506
• Device Catalogue Number: RF*PA35153A
• Device Lot Number: 241024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown