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

Model Number 22438-19

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Contamination /Decontamination Problem (2895)

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

Event Date 07/29/2022

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 delivery catheter.The dc pod damage was confirmed.Additionally, an unknown clear material was noted distal to the end of the dc pod separation for a length of 2mm.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 to insert.It may be possible that the filter was pulled into the pod too quickly or with excessive force causing damage to the dc pod and preventing the filtration element from being able to load properly; however, this could not be determined.The noted clear material at the dc pod separation could be a combination of silicone and fep which is a component of the polyimide tubing of the delivery catheter.Therefore, it has been determined that the clear material at the pod separation was material of the delivery catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

Event Description

It was reported that during device preparation, when loading the filtration element into the delivery catheter (dc), it was noted that the tip of the dc was bent.As a result, the filtration element could not be loaded into the dc pod.The device was not used.There was no patient involvement and no clinically significant delay in the procedure.Another device same size device was used to complete the procedure.Device analysis revealed a contamination / decontamination problem in the dc pod.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: 15595434
• MDR Text Key: 301933856
• Report Number: 2024168-2022-09917
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 1072061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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