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
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.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 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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Visual inspection of the actual device upon receipt it was a guidewire main body.The distal end had been fractured.No fractured piece was returned.Microscopic inspection the outer layer had been elongated and a torn shape was found in the fractured section.The wire had been exposed in the fractured section.No anomaly such as a scratch was found in other sections.Electron microscopic inspection of the wire the side surface of wire at the fractured section was not tapered, and the fractured surface was diagonal.Dimple patterns (hole-shaped 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 1756mm current product: approximately 1800mm compared with the current product, the missing length was likely to be approximately44mm.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 was found in the past.Simulation test regarding the fracture on the guidewire, following simulation test was performed.Repeated 90° bending force was applied to the wire while it got stuck.The side surface of wire at the fractured section was not tapered, and the fractured surface was diagonal.Dimple 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.Based on the investigation result, no anomaly was found in the manufacturing history record and dimensions of the actual device.From the conditions of actual device and simulation test result, as a possible cause of occurrence, it was likely that since repeated bending force was applied, metal fatigue occurred in the actual device, and the wire was fractured.When the device was subsequently removed, pulling force was applied, causing the outer layer to tear, resulting in detachment inside the patient's body.In addition, compared with the current product, it was inferred that the actual device was missing approximately 44mm.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 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.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: 22931465
• Report Number: 9681834-2025-00158
• Device Sequence Number: 16008305
• 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
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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: UNKNOWN CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Male