MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CORSAIR PRO XS; MICROCATHETER

Model Number	CSR150-21S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Per dr.Riley text message, "pro xs 150 got stuck in a septal and wouldn't come out.Luckily tip was married to end of the wire and caught enough to get back into guide and we trapped it out during a live case.Only (about) distal 1mm tip snapped off, not the whole tip.".

• Brand Name: CORSAIR PRO XS
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10681277
• Report Number: 3004718255-2020-00162
• Device Sequence Number: 14255084
• Product Code: DQY
• UDI-Device Identifier: 04547327123679
• UDI-Public: (01)04547327123679(17)221130(10)191224K181
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2020
• Report Date (Section F): 10/14/2020

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: 11/30/2022
• Device Model Number: CSR150-21S
• Device Catalogue Number: CSR150-21S
• Device Lot Number: 191224K181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2020
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/14/2020