MAUDE Adverse Event Report: ASAHI INTECC CORSAIR PRO XS; MICROCATHETER

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While using the svg to rca as a retrograde approach, the corsair pro xs got stuck in a previously placed stent in the svg.When trying to remove the mc, the catheter became trapped on the wire.As dr.Neupane tried to pull the mc back, the hub pulled off the mc and he subsequently had to snare the mc and old stents out.

• Brand Name: CORSAIR PRO XS
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 11237972
• Report Number: 3004718255-2021-00197
• Device Sequence Number: 4371710
• Product Code: DQX
• UDI-Device Identifier: 04547327123662
• UDI-Public: (01)04547327123662(17)230228(10)200228K112
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2021
• Report Date (Section F): 01/27/2021

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: CSR135-21S
• Device Lot Number: 200228K111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/19/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2021
• 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: 01/27/2021