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

Model Number	22437-19
Medical Device Problem Codes	Difficult to Flush (1251); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
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
Nmpa report number is (b)(4).It was reported that the procedure was to treat a lesion in the carotid artery with 90% stenosis.The emboshield nav 6 embolic protection system (eps) was used in the target lesion.The retrieval catheter was being flushed when significant resistance was noted and no liquid flowing out of the quick exchange port.The tip of the retrieval catheter was observed to have a white unidentified substance inside.Another retrieval catheter from a new emboshield nav 6 eps was used to retrieve the filter and complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported damage to the delivery catheter was confirmed.A corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Based on observations from the returned analysis, it is possible that difficulty encountered during loading caused the noted damage to the delivery catheter.It is possible that the filter was pulled into the pod too quickly or with excessive force causing the noted damage to the delivery catheter pod; however, this could not be confirmed.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: 22142499
• Report Number: 2024168-2025-05702
• Device Sequence Number: 12816064
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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
• Patient Sex: Unknown