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

Model Number 40-102

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): INARI MEDICAL ; irvine CA 92618
• MDR Report Key: 12016549
• MDR Text Key: 257197042
• Report Number: MW5101938
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1