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

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per scrub tech-dr.Bisen used a terumo runthrough wire to cross mid cx heavily calcified lesion.First he used a turnpike spiral microcatheter but it was unable to advance across lesion.He then tried corsair pro xs.He was unable to advance across the lesion.When he tried to remove the corsair pro xs, he noticed the microcatheter would not come off wire.He pulled mc and wire out of the guide.He noticed the tip was separated from the shaft and was stuck on the wire.He used another runthrough wire to cross the lesion.Then he used a mamba flex microcatheter and tried to cross the lesion but it wouldn't cross the lesion.He removed the mamba and wire because he noticed that the tip had also separated from the mamba mc.Patient was fine, no adverse outcomes.

• 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: 11350032
• Report Number: 3004718255-2021-00202
• Device Sequence Number: 3383533
• Product Code: DQY
• UDI-Device Identifier: 04547327123662
• UDI-Public: (01)04547327123662(17)230630(10)200720K041
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2021
• Report Date (Section F): 02/19/2021

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CSR135-21S
• Device Lot Number: 200720K041
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2021
• 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: 02/19/2021