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); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
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.Based on the reported information, exchanging the provided barewire filter delivery wire for the 0.014¿ viperwire prevented the ability to retrieve the filter, causing the filter to come off the wire during retrieval resulting in unexpected medical intervention to retrieve the filter with a snare device.The barewire filter delivery wire contains an 0.019¿ step which prevents the filtration element from coming off the distal end of the wire during filter retrieval.The emboshield nav6 instruction for use (eifu)¿ general warnings) states: ¿the emboshield nav6 device can only be used with the barewire filter delivery wire.Use of the device with any guide wire other than the barewire filter delivery wire will lead to loss of the filtration element during the procedure or an inability to retrieve the filtration element¿.The barewire filter delivery wire contains an 0.019¿ step which prevents the filtration element from coming off the wire during filter retrieval.An in-service has been requested to address the ifu violation and how it contributed to the difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - guide wire / fdw selection incorrect.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa).Prior to use the barewire of the large emboshield nav 6 embolic protection system (eps) was exchanged for a.014 viper guide wire (gw).After use in the procedure, when removing the filter, the filter came off the viper gw.Therefore, a snare was used to retrieve the filter.There was 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: 24675607
• Report Number: 2024168-2026-01198
• Device Sequence Number: 10285592
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754(17)280630(10)5071861
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/24/2026

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: 5071861
• 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: 02/27/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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