MAUDE Adverse Event Report: INARI MEDICAL FLOW TRIEVER; CATHETER, EMBOLECTOMY

Device Problem Failure to Align (2522)

Patient Problems Death (1802); Cardiac Tamponade (2226)

Event Date 08/14/2019

Event Type  Death  

Event Description

Catheter failed to track over wire through the heart.Pt with probable right ventricular free wall rupture as a result, and expired on the procedure table due to hemopericardium and tamponade.Fda safety report id# (b)(4).

• Brand Name: FLOW TRIEVER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): INARI MEDICAL
• MDR Report Key: 8944948
• MDR Text Key: 155973931
• Report Number: MW5089447
• 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: Physician
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 74 YR