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

Catalog Number	AP14R324S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Dr (b)(6) was trying to navigate an extremely calcified at cto with no blood flow.He tried traversing around the segment and wire became stuck and when he tried to advance about a 1cm portion of the distal tip came off.Because of where the tip broke and no flow it was determined by physician that leaving where it was would not pose any sort of risk to patient.

• Brand Name: GLADIUS MONGO 14 ES
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 20158906
• Report Number: 3004718255-2024-00337
• Device Sequence Number: 8232533
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)270430(10)240509A151
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/05/2024
• Report Date (Section F): 09/06/2024

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: AP14R324S
• Device Lot Number: 240509A151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2024
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/06/2024