MAUDE Adverse Event Report: ASAHI INTECC, INC. CORSAIR PRO XS; CATHETER

Catalog Number	CSR150-21S
Medical Device Problem Codes	Material Fragmentation (1261); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A sion blue was used to wire a vein graft tied in to the left circumflex.When the corsair pro xs was advanced behind the wire, there were no issues until it reached the anastomosis site at the tip.After meeting resistance, within just a few seconds (<10s) of trying to torque and advance the microcatheter, the operator could feel that it had fused onto the wire.Once this was realized, the wire and microcatheter were removed as a unit.The microcatheter was discarded and another workhorse wire was advanced down the vein graft.During this rewiring under live fluoro, we noticed what looked like balloon radiopaque markers located between the graft markers that weren't there before.Patient was under anesthesia when event occurred and was not affected by the part of the device that was left behind in the vein graft.The patient was also hemodynamically stable before, during, and after the procedure.

• Brand Name: CORSAIR PRO XS
• 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: 23867401
• Report Number: 3004718255-2025-00407
• Device Sequence Number: 11916859
• Product Code: DQY
• UDI-Device Identifier: 04547327123679
• UDI-Public: (01)04547327123679(17)280430(10)250520K021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/22/2025
• Report Date (Section F): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CSR150-21S
• Device Lot Number: 250520K021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2025
• 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: 12/22/2025