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	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pt had a near complete cto of the rca extending from mid-prox rca to the bifurcation of the pda/pl.Prior stent placed at the very distal segment of the rca to the bifurcation.Possible subintimal tracking with re-entry prior to distal stent.Physician belief that subintimal re-entry in stent strut segment.Difficulty advancing mc over mongo.Physicain switched out to pilot 200, wire was able to advance.Wire married to the mc at this time.Xs and pilot 200 removed, physician noted the tip look shredded.Per dr.Kourany, "a sliver of the tip was left in the subintimal space.I believe the tip was deformed passing through the existing stent struts.".

• 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: 14438434
• Report Number: 3004718255-2022-00261
• Device Sequence Number: 14715052
• Product Code: DQY
• UDI-Device Identifier: 04547327123662
• UDI-Public: (01)04547327123662(17)250131(10)220211K061
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/18/2022
• Report Date (Section F): 05/18/2022

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: 01/31/2025
• Device Model Number: CSR135-21S
• Device Catalogue Number: CSR135-21S
• Device Lot Number: 220211K061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/09/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Date Report Sent to FDA: 05/18/2022