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

Model Number	GS3505
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A5: ethnicity: requested, ot provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.Since the actual device was not returned, analysis of it could not be performed.History investigation of the involved product code and lot number.- no anomaly was found in the manufacturing record and the shipping inspection record.- no similar event was found in the past complaint file.Based on the investigation results, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual device was not returned and analysis could not be performed, it was not possible to identify the cause of the occurrence.Ashitaka factory is committed to maintaining the quality of the product by performing following control and inspection.- the guidewire is passed through the dedicated tool on 100% basis to ensure that there is no peeling of the outer layer or adhesion of any foreign matters on the surface of the guidewire.- before the packaging process, 100% visual inspection is performed to ensure that there are no anomalies in appearance such as a peeling of the outer layer or an exposure of the wire strand.Ifu also includes the following descriptions: - do not manipulate or withdraw the glidewire through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.- 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.Continuing to manipulate or rotate the glidewire or 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.Please refer to section h10 for the related reports.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
Terumo medical received an fda medwatch report # mw5180837.The event description states: "during an attempted port-a-cath placement, the coating on the glidewire sheared with a fragment of the coating remaining in the patient's subcutaneous tissue." additional information was received on 14 jan 2026: user error may be to blame as the guidewire was threaded through a needle.The sheared fragment is not causing any issues and has not migrated as it is in the subcutaneous tissue.The estimated blood loss was 5ml.The patient was fine.There was no issue with hemostasis.Only a port-a-cath kit was used with the glidewire.

• 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; reg. no. 9681834; 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: 24308708
• Report Number: 9681834-2026-00011
• Device Sequence Number: 18561866
• Product Code: DQX
• UDI-Device Identifier: 04987350773579
• UDI-Public: (01)04987350773579(17)250930(10)231017
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: 09/30/2025
• Device Model Number: GS3505
• Device Catalogue Number: RF*PA35083A
• Device Lot Number: 231017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: White