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	10/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The marksman catheter tip sheared during procedure.After completion of a cerebral angiogram and thrombectomy when the marksman catheter was removed, it was noted that the tip had sheared.It was removed intact with no complications to the patient.Manufacturer response for catheter, continuous flush, marksman (per site reporter).The rep is aware and plans to pick up the device.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10717946
• Report Number: 10717946
• Device Sequence Number: 16980628
• Product Code: KRA
• UDI-Device Identifier: 00847536026278
• UDI-Public: (01)00847536026278(17)230810(10)220523545
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/15/2020
• Report Date (Section F): 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FA-55160-1030
• Device Lot Number: 220523545
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63
• Date Report Sent to FDA: 10/15/2020