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

Catalog Number	AP14R324P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While working on very calcific and diffusely diseased anterior tibial artery, the mongo es.014 wire became trapped in the distal at by the pedal loop while in the.014 170cm crosswalk.It was noted that when the wire was finally able to be removed, the distal tip of the wire was disconnected from the rest of the wire.A micro snare was used to successfully remove the broken piece of the wire.No issues were noted, and case was terminated.Patient was recovered in the recovery area until hemostasis of femoral site was sealed, then discharged.

• 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: 20364338
• Report Number: 3004718255-2024-00340
• Device Sequence Number: 12458314
• Product Code: DQX
• UDI-Device Identifier: 04547327123754
• UDI-Public: (01)04547327123754(17)270430(10)240508A331
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/03/2024
• Report Date (Section F): 10/03/2024

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: AP14R324P
• Device Lot Number: 240508A331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/25/2024
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/03/2024