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

Model Number 22438-19

Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported pod damage and delivery catheter damage was confirmed.The difficult to insert and slippage of the torque device was unable to be confirmed due to the condition of the returned product.The filtration element was returned on the barewire and was not loaded into the delivery catheter.The membrane was torn, 8mm and 9mm proximal to the tip of the filtration element.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 revealed no other complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty.It may be possible that the filter was pulled into the pod too quickly or with excessive force causing damage to the delivery catheter pod preventing the filtration element from being able to load properly, or the torque device was not securely attached to the barewire resulting in slippage and difficulty loading; however, this could not be confirmed.The additional damage of torn filtration membrane was not reported and likely occurred due to post-use handling or packaging/shipping conditions.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

Event Description

It was reported that during preparation of two emboshield nav6 embolic protection systems (eps) the filter was unable to be pulled into the delivery catheter (dc) pod, both catheters became kinked.Wrinkling was observed after the filter became exposed.The torque device was used; however, the torque device would slip and the wire was pulled and the torque would be readjust.There was no device use or patient involvement, and there was no clinically significant delay in the procedure.The procedure was completed without a filter.Returned device analysis identified a tear of the membrane filter.Additional information was provided that the tear was not observed before or during preparation of the device.No additional information was provided.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16525852
• MDR Text Key: 311231581
• Report Number: 2024168-2023-02565
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2023

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 Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 2102761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1