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

Model Number 22438-19

Device Problems Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during preparation of a large nav6 emboshield embolic protection system (eps), a bubble was observed inside the filer indicating a possible leak.A decision was made not use the eps inside the patient.The procedure was successfully completed with a new nav 6.There was no patient involvement no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was corrected.It was reported that preparation of the large nav6 emboshield embolic protection system (eps) was difficult as an air bubble could not be cleared.No additional information was provided.

Manufacturer Narrative

The device was returned.Visual and functional analysis was performed on the returned product.The reported difficulty preparing/flushing the device was unable to be 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 identified no other similar complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulty.It is possible that reported air bubble originated from the syringe during flushing, however, the syringe tip was not returned, and 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.

• 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
• MDR Report Key: 9885512
• MDR Text Key: 185230865
• Report Number: 2024168-2020-02986
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 9122061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1