MAUDE Adverse Event Report: ASAHI INTECC GLADIUS GUIDEWIRE

Catalog Number	PPW18R300S
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Guide wire broke inside the patient and the piece was retrieved with a snare.

• Brand Name: GLADIUS GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 22866481
• Report Number: 3004718255-2025-00391
• Device Sequence Number: 18476283
• Product Code: DQX
• UDI-Device Identifier: 04547327106726
• UDI-Public: (01)04547327106726(17)270831(10)240909A411
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2025
• Report Date (Section F): 08/20/2025

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 Catalogue Number: PPW18R300S
• Device Lot Number: 240909A411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/20/2025