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
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
• MDR Report Key: 24308707
• Report Number: 2243441-2026-00002
• Device Sequence Number: 13181608
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/10/2026
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/13/2026
• Device Age: 25 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: White
• Date Report Sent to FDA: 02/10/2026