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

Model Number	GS3510
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported they were unable to backload a catheter onto the wire.When trying to backload the catheter on to the wire, the hydrophilic material at the back of the wire would bunch up and prevent the catheter from being advanced.The wire was removed and a new glidewire was inserted.The case was completed with no further issues.No blood loss.There was no patient injury and/or require medical or surgical intervention.No blood loss was reported.Additional information was received on 09jan2025: the procedure performed was an aortagram with runoff of lower leg.There was no impact to the patient from the hydrophilic material bunching up.The wire was exposed when the hydrophilic material bunched up.

• 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: 21293331
• Report Number: 2243441-2025-00001
• Device Sequence Number: 15421569
• Product Code: DQX
• UDI-Device Identifier: 04987350773678
• UDI-Public: (01)04987350773678(17)260331(10)240424
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2025
• Report Date (Section F): 02/03/2025

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: 03/31/2026
• Device Model Number: GS3510
• Device Catalogue Number: RF*PA35265A
• Device Lot Number: 240424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/07/2025
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2025
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 02/03/2025