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

Catalog Number 22442-19

Device Problems Difficult to Insert (1316); Material Separation (1562); Material Twisted/Bent (2981)

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

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficulty to insert was unable to be confirmed due to the condition of the returned device.The reported dc pod damage 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 identified no indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported difficulty.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 determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

Event Description

It was reported that during preparation of the emboshield nav 6, the filter was difficult to insert in the delivery catheter (dc) pod.There was bunching or wrinkling observed on the delivery catheter pod prior to loading.The torque device was used when pulling the filter element into the delivery catheter pod.Another emboshield nav 6 was used to complete the procedure.There was no device use or patient involvement and there was no clinically significant delay in the procedure.Returned device analysis identified the delivery catheter was separated at the distal end of the marker band.The account confirmed that separation occurred during preparation of the filter and did not enter the patient at all.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: 15563153
• MDR Text Key: 302940062
• Report Number: 2024168-2022-10403
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22442-19
• Device Lot Number: 1060762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• 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
• Patient Sex: Female