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

Catalog Number 22437-19

Device Problems Break (1069); Difficult to Insert (1316); Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) - permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 an emboshield nav6 embolic protection system (eps) difficulty inserting the filter into the delivery catheter was noted and when the device was pulled out of the hoop, the filter was out.The eps was not used and the procedure was successfully completed with an unspecified device.There were no adverse patient effects and no clinically significant delay in the procedure.The return device analysis identified that the delivery catheter shaft sleeve was detached 7mm distal to the guide wire exit port.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual, dimensional and functional analysis was performed on the returned device.The reported difficult to insert and premature deployment was unable to be confirmed due to the condition of the returned 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.However, based on the reported information and other complaints related to difficult to insert/load the device, it has been determined that a potential product quality issue exist.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 8879876
• MDR Text Key: 153868955
• Report Number: 2024168-2019-10703
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 22437-19
• Device Lot Number: 8101761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1