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

Model Number 22438-19

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported difficult to insert was unable to be replicated in a testing environment due to the condition of the returned device.The reported material split, cut or torn was able to be confirmed.The length of the dc pod was determined to be undersized.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 did not indicate a lot specific quality issue.Reportedly, the torque device was not used to pull the filter into the dc pod.It should be noted that the emboshield nav6 embolic protection system instructions for use (ifu) states: carefully pull the torque device in a controlled manner to retract the barewire filter delivery wire and observe the filtration element being retracted through the loading funnel into the delivery catheter pod.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the filter was pulled into the pod too quickly and/or the reported ifu deviation of not using the torque device to load the filter in the delivery catheter resulted in the reported material split, cut or torn/noted dc pod damages (radial and longitudinal tear) thus resulting in the reported difficult to insert.The noted multiple bends in the entire length of the shaft likely occurred during handling or packing for return analysis.The noted pod length and filter measuring out of specification is possibly a result of the reported difficulties and a result of the reported/noted damages compromising the pod and filter; however this cannot be confirmed and does not appear to be related to a manufacturing issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during preparation, when the physician pulled the barewire of the emboshield nav6 embolic protection system (eps) to pull the filter into the delivery catheter pod, it was found that the tip of the delivery catheter had split in two.There was resistance when pulling the filter into the delivery catheter.The torque device was not used.There was no reported device use or patient involvement.A new emboshield nav6 eps was used to complete the procedure.There was no reported clinically significant delay in the procedure.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: 13455982
• MDR Text Key: 288809929
• Report Number: 2024168-2022-01192
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 0072261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2020
• 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