MAUDE Adverse Event Report: INARI MEDICAL - OAK CANYON THROMBECTOMY DEVICE; CATHETER, EMBOLECTOMY

Device Problem Failure to Cut (2587)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Inari thrombectomy device was severed as it was being removed from a vein.It was never dislodged or lost in the vein.The physician was able to safely remove all parts out of the device and hemostasis was achieved by inserting a new vascular sheath.Fda safety report id # (b)(4).

• Brand Name: THROMBECTOMY DEVICE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): INARI MEDICAL - OAK CANYON; irvine CA 92618
• MDR Report Key: 13043078
• MDR Text Key: 282631492
• Report Number: MW5106151
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR