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

Model Number	CSR150-21S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Rotablator case initially used mamba catheter to attempt to cross lesion and was unsuccessful.Used corsair xs to cross the took rotablator wire down lad to rotablate vessel.When trying to exchange the wire over the corsair xs after rotablating the wire got stuck at the tip of the catheter.At which point physician pulled both catheter and wire out together.Examination of the tip of the catheter showed damage with tip separation.

• 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: 10797652
• Report Number: 3004718255-2020-00166
• Device Sequence Number: 2954026
• Product Code: DQY
• UDI-Device Identifier: 04547327123679
• UDI-Public: (01)04547327123679(17)221031(10)191107K081
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2020
• Report Date (Section F): 11/05/2020

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: No Information
• Device Expiration Date: 10/31/2022
• Device Model Number: CSR150-21S
• Device Catalogue Number: CSR150-21S
• Device Lot Number: 191107K081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/26/2020
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• 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: 11/05/2020