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

Model Number 22437-19

Device Problems Difficult to Insert (1316); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

A visual, dimensional and functional analysis was performed on the returned device and the inner diameter of the dc pod was noted to be undersized.The reported difficulty 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.Additionally, a review of the complaint history identified no indication of a lot specific product quality issue.Measurements were taken of the pod inner diameter.Per the specification, the pod inner diameter should be a minimum diameter of 0.0345 inches.Using a 0.0345inch pin gauge, approximately.25mm was advanced and then resistance was noted.Therefore, the pod inner diameter did not meet the specification.The investigation was unable to determine a conclusive cause for the reported difficulty.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.Na.

Event Description

It was reported that during preparation of an emboshield nav6, the filter was unable to load onto the delivery catheter (dc) pod.Another emboshield nav6 was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay.No additional information was provided.Device analysis noted the inner diameter of the dc pod was undersized.

• 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: 10234019
• MDR Text Key: 197617429
• Report Number: 2024168-2020-05482
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 0010762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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