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

Model Number 22437-19

Device Problems Difficult to Insert (1316); Material Separation (1562); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

A visual, dimensional, and functional analysis was performed on the returned device.The reported difficulty to insert was unable to be confirmed due to the condition of the returned dc pod.The damage to the delivery catheter pod was confirmed.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 similar complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.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; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

Event Description

It was reported that when during preparation of the emboshield nav6 embolic protection system (eps), the filter could not be loaded into the delivery catheter pod and the tip of the delivery catheter was noted to be kinked.There was bunching/wrinkling noted on the delivery catheter pod but it was observed after loading was attempted.Therefore, the device was not used and there was no patient involvement.Another emboshield nav6 was used to complete the procedure.There was no clinically significant delay in the procedure.Returned device analysis identified that the dc pod was separated and torn and the separated portion was not returned.Follow up with the account confirmed they were not aware and the separated portion was discarded.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: 13454611
• MDR Text Key: 288785100
• Report Number: 2024168-2022-01188
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 0092361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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