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

Model Number 22437-19

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

It was reported that during preparation of the emboshield nav6 embolic protection system (eps), there was difficulty inserting the filter into the delivery catheter (dc) pod and the delivery catheter was kinked.Additionally there was some bunching and wrinkling observed on the delivery catheter pod after attempting to pull the filter into the dc pod.The torque device was not used.There was no reported device use or patient involvement.Another, same size emboshield nav6 was used to complete the procedure.There was no reported clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a split/torn delivery catheter pod.

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 twisted / bent (bunching, wrinkling) was unable to be confirmed however there were other dc pod damages (split, separated).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.In this case it is undetermined if the ifu deviation caused/contributed to the reported difficulties.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that the filter was pulled into the pod too quickly or with excessive force resulting in the reported/noted dc pod damages (split, separated); thus resulting in the reported difficult to insert.Manipulation of the device resulted in the noted barewire coil damage (stretched).The noted multiple bends on the delivery catheter shaft likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 13426033
• MDR Text Key: 288784283
• Report Number: 2024168-2022-01132
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 0092361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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