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

Model Number	CSR135-21S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) is working on cx cto.Was able to get gladius mongo gw across cto.He was using a mamba flex mc first.That was unable to cross cto.He asked for corsair pro xs.Was able to advance further, but not totally across cto cap.He did clockwise and counter-clockwise rotations.The cp xs was not advancing ay further.He then went to remove the cp xs.He noticed that the tip of cp xs was broken off, and was stuck on wire.On angio it didn't look like there was calcium but cto cap was extremely hard.Once he removed the body of the cp xs, he removed the gladius mongo guidewire, which had the tip on the mc fused to the wire.So entire tip was removed from patient, nothing left behind.He rewired the vessel, but was unable to advance any microcatheter, or balloon through the cto cap.

• 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: 10646533
• Report Number: 3004718255-2020-00161
• Device Sequence Number: 3656613
• Product Code: DQY
• UDI-Device Identifier: 04547327123662
• UDI-Public: (01)04547327123662(17)220930(10)191023K061
• 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): 10/06/2020
• Report Date (Section F): 10/07/2020

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: 09/30/2022
• Device Model Number: CSR135-21S
• Device Catalogue Number: CSR135-21S
• Device Lot Number: 191023K061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/06/2020
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 10/07/2020