MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6; EMBOLIC PROTECTION SYSTEM

Model Number 22438-19

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported during preparation of a emboshield nav6 that the delivery catheter became kinked and wrinkled.A tear at the shaft was also noted.Another emboshield was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Visual, dimensional and functional analysis was performed on the returned device.The reported deformation, material split, and material bent were confirmed.The original loading tray was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported deformation, material split, and material bent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

• Brand Name: EMBOSHIELD NAV6
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10526026
• MDR Text Key: 206765446
• Report Number: 2024168-2020-07640
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 8100961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1