MAUDE Adverse Event Report: ASAHI INTECC SASUKE; PERCUTANEOUS CATHETER

Catalog Number	SA145-33N
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
While working on wiring the distal bifurcation of the rca; sasuke tip became entrapped and separated from body of catheter.Tip was left in rca and trapped behind a stent.

• Brand Name: SASUKE
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 21289021
• Report Number: 3004718255-2025-00371
• Device Sequence Number: 9355432
• Product Code: DQY
• UDI-Device Identifier: 04547327120197
• UDI-Public: (01)04547327120197(17)270630(10)240702F041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/31/2025
• Report Date (Section F): 01/31/2025

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
• Device Catalogue Number: SA145-33N
• Device Lot Number: 240702F041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/22/2025
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/31/2025