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

Model Number	22438-19
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous superficial femoral artery lesion using an emboshield nav6 embolic protection system (eps).When the eps was inserted into the anatomy, it was noted that the filter wasn't pulled all the way into the pod; therefore, resistance was felt getting the filter and barewire to the target lesion.An attempt was made to deploy the filter, but the barewire did not move the filter.It was noted that the tip of the barewire had bent and separated.The eps was removed from the patient and the procedure continued.Post treatment, a balloon was used to push the separated tip into the vessel wall.No additional information was provided.
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, based on the information, the difficulties appear to be due to circumstances of the procedure.It is likely that the filter was not fully collapsed in the delivery catheter pod prior to insertion in the patient causing the reported resistance during advancement.Additionally, it is likely that advancing the delivery catheter against resistance caused damage to the delivery catheter resulting in deployment failure and causing the barewire tip to bend and separate.As a result, a balloon was used to push the separated tip into the vessel wall.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 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: 24691867
• Report Number: 2024168-2026-01231
• Device Sequence Number: 9706189
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754(17)280331(10)5041661
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/25/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 5041661
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic