MAUDE Adverse Event Report: ABBOTT VASCULAR INC. EMBOSHIELD NAV6; Temporary Carotid Catheter for Embolic Capture

Model Number	22438-19
Medical Device Problem Codes	Retraction Problem (1536); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a mildly calcified and tortuous lesion in the internal carotid artery.The nav6 embolic protection system (eps) was advanced to the target lesion and the filter deployed.After stent deployment was completed, during retrieval of the embolic protection filter, the tip of the retrieval catheter became entangled with a stent strut, preventing normal retrieval.Repeated advancement attempts resulted in tearing of the retrieval catheter tip.The retrieval catheter was subsequently withdrawn, and the delivery catheter was used to successfully retrieve the filter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported the procedure was to treat a mildly calcified and tortuous lesion in the internal carotid artery.The nav6 embolic protection system (eps) was advanced to the target lesion and the filter deployed.After stent deployment was completed, during retrieval of the embolic protection filter, the tip of the retrieval catheter became entangled with a stent strut, preventing normal retrieval.Repeated advancement attempts resulted in tearing of the retrieval catheter tip.The retrieval catheter was subsequently withdrawn, and the delivery catheter was used to successfully retrieve the filter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported retraction problem and damage (tear) to the retrieval catheter was unable to be confirmed as the retrieval catheter was not returned.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficulty retrieving the filter and damage to the retrieval catheter appears to be related to circumstances of the procedure.In this case, it is likely that the tip of the retrieval catheter interacted with the newly placed stent resulting in the inability to retrieve the filter and damage to the retrieval catheter tip.As a result, unexpected medical intervention was required to retrieve the filter using the delivery catheter.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: EMBOSHIELD NAV6
• Common Device Name: Temporary Carotid Catheter for Embolic Capture
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50127585
• Report Number: 2024168-2026-03055
• Device Sequence Number: 16071861
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754(17)280630(10)5072161
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K191173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 5072161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown