MAUDE Adverse Event Report: ASAHI INTECC CORSAIR PRO; MICROCATHETER

Model Number	CSR150-26P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.Was attempting to cross lesion with corsair pro microcatheter but was unsuccessful.After removing the catheter from the body over the wire he noted the tip to be shredded.No fragments noted to be within the patient or access site according to dr.Was saved to be returned for inspection.Patient sustained no injury.

• Brand Name: CORSAIR PRO
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 16792359
• Report Number: 3004718255-2023-00294
• Device Sequence Number: 5580037
• Product Code: DQY
• UDI-Device Identifier: 04547327111850
• UDI-Public: (01)04547327111850(17)250930(10)221015K27A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/21/2023
• Report Date (Section F): 04/21/2023

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: 09/30/2025
• Device Model Number: CSR150-26P
• Device Catalogue Number: CSR150-26P
• Device Lot Number: 221015K27A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2023
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 04/21/2023