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

Model Number	EWR6025
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the product the tip fragmented during an ercp procedure while the device was being maneuvered past as tight stricture.The product was discarded following the procedure, and the exact date of the procedure was unknown.The procedure type was therapeutic.There was no serious injury and/or an adverse effect.

• 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: 22320705
• Report Number: 2243441-2025-00031
• Device Sequence Number: 8812839
• Product Code: DQX
• UDI-Device Identifier: 04987350755476
• UDI-Public: (01)04987350755476(17)251130(10)231225
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2025
• Report Date (Section F): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: EWR6025
• Device Catalogue Number: RF*GA25263E
• Device Lot Number: 231225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2025
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/24/2025