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

Model Number	22437-19
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the internal carotid artery, de novo, with mild calcification, mild tortuosity and 80% stenosis.The emboshield nav6 embolic protection system (eps) was advanced to the lesion and the filter was deployed.Reportedly due to the tortuous anatomy, the 6fr guiding catheter had insufficient support and the delivery catheter and filter of the emboshield nav6 fell off [dislodged] from the rest of the device but did not separate or break.The emboshield nav6 eps filter and delivery catheter were removed immediately with the 6fr guiding catheter.After removal from the anatomy, it was attempted to pull the filter into the delivery catheter and it was noted the delivery catheter tip was bent.An 8fr guiding catheter was advanced and a new emboshield nav6 eps was used to complete the procedure.There were no reported adverse patient effects and there was no reported 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
Subsequent to the previous filed report it was stated that the filter became displaced during use.The filter was simply removed from the anatomy at the same time as a 6fr guiding catheter.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection, functional testing, and dimensional analysis was performed on the returned device.The reported kink was confirmed.The reported dislodgment was not 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 specific issue.Based on reported information and observations from the returned analysis, it is likely that insufficient support with the guiding catheter due to anatomical conditions contributed to the delivery catheter becoming kinked.As a result of the damage to the delivery catheter, the filter likely deployed while advancing through the guiding catheter.There was no separation or dislodgment of the filter observed.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: 21596602
• Report Number: 2024168-2025-02619
• Device Sequence Number: 8266227
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)270331(10)4042361
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 4042361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR GUIDING CATHETER
• Patient Sex: Unknown