MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV 6; EMBOLIC PROTECTION SYSTEM

Model Number 22438-19

Device Problems Break (1069); Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that during preparation of the emboshield nav6 embolic protection system, the filtration element failed to load into the delivery catheter and the support structure of the filtration element became deformed (bent) and the pod wrinkled.The torque device was not used.There was no patient involvement.A new emboshield nav6 was used to successfully continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis identified the filtration element support structure to be broken.

Manufacturer Narrative

Visual and dimensional analysis was performed on returned device.The reported difficult to insert was unable to confirmed.The pod damage was confirmed and likely due to handling while attempting to load the device.It should be noted that per the instructions for use for the embolic protection system, emboshield nav6, section 8.2 states to carefully pull the torque device in a controlled manner to load the filtration element into the delivery catheter pod.The investigation determined that the reported difficulty appears to be related to circumstances of the procedure.Based on the reported information, it is likely that the black handle was pulled inadvertently instead of the torque device and barewire while trying to load the filter into the delivery catheter resulting in the pod damages.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: EMBOSHIELD NAV 6
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9717412
• MDR Text Key: 179718987
• Report Number: 2024168-2020-01530
• 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: 03/25/2020

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
• Device Expiration Date: 07/31/2022
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 9080861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1