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

Model Number	GS3509
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the distal portion of the wire had its hydrophilic coating shear off.This resulted in catheters being unable to pass over it and caused the physician to lose wire access.The type of procedure performed was a leg angiogram.The patient's condition was stable.The estimated blood loss was less than 250cc.The event occurred intra-operative.Additional information was received on 28 may 2025: the sample is contaminated with blood but not with infectious agents or anti-cancer agents.The reported event did not result in patient injury or require medical or surgical intervention.

• 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: 22298675
• Report Number: 2243441-2025-00027
• Device Sequence Number: 9227706
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: (01)04987350773654(17)260630(10)240722
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025
• Report Date (Section F): 06/20/2025

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: 06/30/2026
• Device Model Number: GS3509
• Device Catalogue Number: RF*PA35263A
• Device Lot Number: 240722
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2025
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/20/2025