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

Model Number	GS3509
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age or date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: requested, not provided due to hospital policy.A6: race: requested, not provided due to hospital policy.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 glidewire was being used to go subintimal in an attempt to cross a calcified chronic total occlusion (cto) lesion.The tip got stuck and broke off in the lesion when pulled out.The procedure performed was a peripheral angioplasty.There was no blood loss and no patient injury.Additional information was received on 03jul2025: they left the piece in the patient, it was a calcified chronic total occlusion (cto) lesion so there was no harm to the patient, as there was already no flow in the vessel where the wire tip broke off.The wire fragment was approximately 1-2cm.
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.No exposure of the wire 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 guidewire main body was removed to confirm the condition of wire at the fractured section.The side surface of wire at the fractured section had been curved.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 2570mm.Current product: approximately 2600mm.The total length of actual device met the factory's specifications.However, compared with the current product, the missing length was likely to be approximately 30mm.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.Udi no.(b)(4).Simulation test: regarding the fracture on the guidewire, following simulation test was performed.Repeated 180° bending force was applied to the wire.The side surface of wire at the fractured section was curved.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 180° 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, the total length of actual device met the factory's specifications.However, compared with the current product, it was inferred that the actual device was missing approximately 30mm.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.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• 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: 22465614
• Report Number: 9681834-2025-00132
• Device Sequence Number: 4234878
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: (01)04987350773654(17)260531(10)240603
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 05/31/2026
• Device Model Number: GS3509
• Device Catalogue Number: RF*PA35263A
• Device Lot Number: 240603
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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: .035 QUICKCROSS.; 4FR ANGLED GLIDECATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown