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 Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure performed was to treat 100% in-stent restenosis in a heavily calcified, mildly tortuous superficial femoral artery.The large emboshield nav6 embolic protection system (eps) was advanced and subsequently, the 7.0x150mm jade 18 balloon dilatation catheter appeared to have entered through the wire exit port on top of the eps filter.Upon withdrawal of the jade balloon, the eps filter was inadvertently getting withdrawn as well and the two devices were stuck.An unspecified device was used to complete the procedure.There were no adverse patient effects and no clinically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.
Event or Problem Description
Subsequently after the initial report was filed, it was noted that the polyimide olive (connector piece inside the filter device) of the eps, was torn and stretched.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported filter damage was confirmed.The reported difficulty removing could not be replicated in a testing environment as it was based on operational circumstance.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.It was reported that the jade balloon catheter was advanced too far on the wire causing the tip of the balloon catheter to become stuck on the proximal neck of the emboshield filter.It should be noted that the emboshield nav6 instruction for use (ifu) states: maintain adequate distance between the proximal tip of the filtration element and the most distal tip of any interventional device.In this case, failing to keep adequate distance between the jade balloon catheter and emboshield filter appear to be the likely cause of the difficulties.Based on the reported information and observations from the returned analysis, the reported difficulty removing and damage to the filter appears to be due to circumstances of the procedure.It is likely that the jade balloon catheter was advanced too far on the wire causing the tip of the balloon catheter to become stuck on the proximal neck of the emboshield filter.The condition of the returned filter indicates that the filter had slightly prolapsed as the jade catheter collided with the filter causing the noted stretched and torn damage.The difficulty removing was a result of the jade catheter tip being stuck over the proximal neck of the emboshield filter causing the filter to withdraw with the catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.A2, a3: patient information updated h6: medical device problem code 2017 - failure to follow steps.

• 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: 24663799
• Report Number: 2024168-2026-01156
• Device Sequence Number: 14731809
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754(17)270930(10)4101461
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 4101461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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 Age: 82 YR
• Patient Sex: Male