MAUDE Adverse Event Report: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number 22443-19

Device Problems Break (1069); Premature Activation (1484)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported premature activation was confirmed as the filter was returned outside of the delivery catheter.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 indication to suggest a lot specific product quality issue exists.The investigation was unable to determine a cause for the reported premature activation.It may be possible that during advancement, the noted damage to the delivery catheter pod occurred resulting in the filter deploying prematurely; however, this could not be confirmed.Additional information received from the account stated the break in the filter support structure may have occurred at the end of the procedure, as the customer was packaging the device; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat the internal carotid area.The emboshield nav6 embolic protection system (eps) filter opened [prematurely deployed] during advancement.There was no adverse patient effects reported and no clinically significant delay reported.Per device analysis it was identified that filtration element support structure was broken, but not separated into two separate pieces.No additional information was provided.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• MDR Report Key: 18714010
• MDR Text Key: 335702369
• Report Number: 2024168-2024-01883
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• 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
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22443-19
• Device Lot Number: 2081761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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