MAUDE Adverse Event Report: INARI MEDICAL CLOTTRIEVER CATHETER THROMBECTOMY; CATHETER, CONTINUOUS FLUSH

Model Number	40-102
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This product is used in a thrombectomy procedure.It is normally inserted into the body, brought out of the body, thrombi/clots are removed from the catheter, and the catheter is reinserted again to repeat the process.This was inserted into the patient and brought out of the patient and before it was reinserted, the catheter should be resheathed.There was difficulty in resheathing the catheter so it was not able to be reused.Fda safety report id# (b)(4).

• Brand Name: CLOTTRIEVER CATHETER THROMBECTOMY
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): INARI MEDICAL ; irvine CA 92618
• MDR Report Key: 12016549
• Report Number: MW5101938
• Device Sequence Number: 11615836
• Product Code: KRA
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: 10/12/2022
• Device Model Number: 40-102
• Device Lot Number: 20100015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1