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

Catalog Number	SA145-33N
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician used sasuke for om1 access from the circumflex.While trapping out the dual lumen catheter, the distal portion of the sasuke catheter snapped inside of the guide catheter.This was not clear until the physician advanced a balloon through the guide catheter and into the circumflex, which caused the broken-off piece of the sasuke to fall into the circumflex.There were no adverse events from the piece of the sasuke catheter.The patient was fine and the case proceeded as normal.The broken-off piece of the sasuke was retrieved using two different wires and twisting them until they trapped the piece and it was able to be pulled into the guide catheter and trapped out.

• 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: 23305093
• Report Number: 3004718255-2025-00396
• Device Sequence Number: 9980477
• Product Code: DQY
• UDI-Device Identifier: 04547327120197
• UDI-Public: (01)04547327120197(17)280430(10)250513F011
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/15/2025
• Report Date (Section F): 10/15/2025

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: 250513F011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/15/2025