MAUDE Adverse Event Report: ASAHI INTECC CORSAIR PRO XS; MICRO CATHETER

Model Number	CSR135-21S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Tip was dislodged in lesion.

• Brand Name: CORSAIR PRO XS
• Common Device Name: MICRO CATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 14367144
• Report Number: 3004718255-2022-00260
• Device Sequence Number: 4712358
• Product Code: DQY
• UDI-Device Identifier: 04547327123662
• UDI-Public: (01)04547327123662(17)240930(10)211008K171
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/11/2022
• Report Date (Section F): 05/11/2022

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: 09/30/2024
• Device Model Number: CSR135-21S
• Device Catalogue Number: CSR135-21S
• Device Lot Number: 211008K171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Date Report Sent to FDA: 05/11/2022