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

Model Number 22438-19

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional devices referenced is being filed under a separate medwatch report#.

Event Description

It was reported that during preparation of the emboshield nav6 embolic protection system, a thick/sticky white material was seen in the tip of the recovery catheter after flushing.The device was not used.A second nav6 system was opened but the same white stuff was seen in the tip again.A third nav6 system was opened and was used to successfully complete the procedure.There was no patient involvement with the first two systems.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported contamination was confirmed.The noted fibers are likely caused by case circumstances as the polytetrafluoroethylene (ptfe) is a sticky substance that may have been adhered during return analysis or at the account.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 other similar incidents reported from this lot.The investigation determined that case circumstances was the likely cause for the reported contamination.The white stuff or foreign material that was observed on the returned retrieval catheter during the procedure, appears to be excess ptfe lubricant, which is applied during manufacturing and serves to aid in retrieval of the filtration element during use.It is likely that during flushing, the lubricant was flushed out of the distal end of the retrieval catheter causing it to become exposed.The noted fibers are likely caused by case circumstances as the ptfe is a sticky substance that may have been adhered during return analysis or at the account.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
• MDR Report Key: 11509549
• MDR Text Key: 242387364
• Report Number: 2024168-2021-02124
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 0081161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1