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); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficult to insert could not be replicated due to the condition of the returned device.The reported pod damage was not noted.The reported barewire tip separation was confirmed.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 of specific issue.Based on observations from the returned analysis, the reported difficulty loading the filter and barewire tip separation appears to be related to operational context.It is likely that during preparation of the device, and during removal from the loading tray, the tip of the barewire became compromised due to inadvertent mishandling causing the noted core separation.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 during preparation of the large emboshield nav 6 embolic protection system (eps), the delivery catheter (dc) pod became bent when loading the filter into the dc pod.The core of the barewire became separated.Therefore, the eps was not used in the procedure.Another emboshield eps was used to continue the procedure.There was no patient involvement and no clinically significant delay reported 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: 24041262
• Report Number: 2024168-2026-00221
• Device Sequence Number: 16076918
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754(17)270630(10)4072261
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: 4072261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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