MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Catalog Number 22438-19

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2019

Event Type  malfunction  

Event Description

Physician attempted to deploy the device, however the device would not fully open on the guidewire.When the physician attempted to inspect the device, the device fell off the guidewire.

• Brand Name: EMBOSHIELD NAV6
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 9238767
• MDR Text Key: 163767939
• Report Number: 9238767
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22438-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 29