MAUDE Adverse Event Report: ASAHI INTECC, INC. ASAHI SASUKE; CATHETER

Catalog Number	SA145-33N
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Very complex case; using sasuke at the pda.Tip broke off.

• Brand Name: ASAHI SASUKE
• Common Device Name: CATHETER
• Manufacturer (Section D): ASAHI INTECC, INC.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 23373264
• Report Number: 3004718255-2025-00398
• Device Sequence Number: 18629588
• Product Code: DQY
• UDI-Device Identifier: 04547327120197
• UDI-Public: (01)04547327120197(17)280430(10)250515F031
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/23/2025
• Report Date (Section F): 10/23/2025

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: SA145-33N
• Device Lot Number: 250515F031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2025
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• 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: 10/23/2025