MAUDE Adverse Event Report: ABBOTT VASCULAR INC. EMBOSHIELD NAV6; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number	22438-19
Medical Device Problem Codes	Difficult to Insert (1316); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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.In this case, it is possible that the filter was pulled into the pod too quickly or with excessive force causing damage to the delivery catheter pod preventing the filtration element from being able to load properly.Additionally, it is possible that during the attempt to load the filter, excessive force was applied to the delivery catheter handle causing the handle to break or separate.However, without having the device to examine, this could not be confirmed.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.
Event or Problem Description
It was reported that prior to use of the emboshield nav 6 embolic protection system (eps), during prep, the filter could not be inserted into the delivery catheter (dc) pod.The device was pulled and the tray was pushed down but the filter would not go in and the deployment handle ended up separating.The device was not used and there was no patient involvement.A new emboshield was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

• 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 2807
• 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: 23945644
• Report Number: 2024168-2026-00024
• Device Sequence Number: 12720135
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754(17)280531(10)5061161
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 5061161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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
• Patient Sex: Unknown