MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO 14; GUIDEWIRE

Catalog Number	AP14R023S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of mongo wire broke off while trying to cross rca in-stent restenosis lesion.Wire was able to be snared out and case completed.Patient was doing fine and procedure was a success.

• Brand Name: GLADIUS MONGO 14
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 20789982
• Report Number: 3004718255-2024-00344
• Device Sequence Number: 18116579
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)270531(10)240531A421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/26/2024
• Report Date (Section F): 11/26/2024

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: AP14R023S
• Device Lot Number: 240531A421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/20/2024
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• 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: 11/26/2024