MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO; GUIDE WIRE

Catalog Number	PP18R304S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Accessed the posterior tibial artery and attempted to cross retrograde fashion.Unsuccessful so we stuck antegrade common femoral artery and attempted to cross is that fashion.Tried to engage the medial tract of the proximal cap and the wire twisted around itself.At that point we removed the wire and noticed there was still some of the tip of the navicross.We removed the navicross and pushed the remaining portion of the wire out of the catheter and you could see the act fall apart on the table.No parts remained in the patients body after the procedure.Continued with the procedure and crossed lesion and treated and had a successful case.

• Brand Name: GLADIUS MONGO
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 19160959
• Report Number: 3004718255-2024-00328
• Device Sequence Number: 7455846
• Product Code: DQX
• UDI-Device Identifier: 04547327143219
• UDI-Public: (01)04547327143219(17)260731(10)230807A211
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/22/2024
• Report Date (Section F): 04/22/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: PP18R304S
• Device Lot Number: 230807A211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2024
• 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: 04/22/2024