MAUDE Adverse Event Report: ASAHI INTECC CORSAIR PRO 150; MICOROCATHETER

Catalog Number	CSR150-26P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Btk cto case with noted ca++.Unable to advance primary guidewire (prowater) , so corsair pro (cp) advanced otw to facilitate.Cp torqued x3 rotations and primary operator noted that tip was separated from device.Cp removed from body and snare advanced to retrieve tip of catheter.No pt sequelae noted.No retainment of any part of device.Procedure completed successfully after conversion to turnpike spiral and more aggressive wire (b)(4).Pt discharged same day.Physician stated device driven into proximal cap before torquing.

• Brand Name: CORSAIR PRO 150
• Common Device Name: MICOROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 13026606
• Report Number: 3004718255-2021-00248
• Device Sequence Number: 17171632
• Product Code: DQY
• UDI-Device Identifier: 24547327111854
• UDI-Public: (01)24547327111854(17)240531(10)210531K03A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/17/2021
• Report Date (Section F): 12/17/2021

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: 05/31/2024
• Device Catalogue Number: CSR150-26P
• Device Lot Number: 210531K03A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White
• Date Report Sent to FDA: 12/17/2021