MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55160-1030
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
When backing the catheter off wire, the catheter became stuck.The whole construct had to be removed from patient during a crucial time of trying to retrieve clots from a stroke patient.No harm caused to patient.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 5290 california avenue; irvine CA 92617
• MDR Report Key: 11559546
• Report Number: 11559546
• Device Sequence Number: 4767371
• Product Code: KRA
• UDI-Device Identifier: 00847536026278
• UDI-Public: (01)00847536026278(17)230911(10)220752941
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/22/2021
• Report Date (Section F): 03/22/2021

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 Model Number: FA-55160-1030
• Device Lot Number: 220752941
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 117
• Date Report Sent to FDA: 03/22/2021