MAUDE Adverse Event Report: ABBOTT CARDIOVASCULAR / ABBOTT VASCULAR EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM 7.2 MM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Lot Number 1102961

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/14/2022

Event Type  Injury  

Event Description

Abbott emboshield nav6 embolic protection system detached in pt.Physician had to use snare device to remove detached portion from pt.Device given to dept mgr.Factual description per event summary, surgeon confirmed no harm or detrimental impact to pt regarding this device failure.Also, confirmed that device in its entirely was successfully removed.Physician indicated this is an isolated incident.He has done thousands of these procedure with this device.This is the first instance he has encountered.He also indicated that the pt's anatomy (angle of aortic bifurcation} necessitated a sharper turn through the aortic bifurcation while using the device.Physician believed this is a "one-off" situation.

• Brand Name: EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM 7.2 MM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): ABBOTT CARDIOVASCULAR / ABBOTT VASCULAR; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 14934202
• MDR Text Key: 295429733
• Report Number: MW5110674
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1102961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American