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

Model Number	22437-19
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
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
It was reported during the procedural preparation of an emboshield nav 6 that the filter could not be loaded into the delivery catheter because the delivery catheter was noted to be broken.Another emboshield was used and the procedure was completed.There was no patient involvement and no clinically significant delay.No additional information was provided.
Event or Problem Description
It was reported during the procedural preparation of an emboshield nav 6 that the filter could not be loaded into the delivery catheter because the delivery catheter was noted to be broken.Another emboshield was used and the procedure was completed.There was no patient involvement and no clinically significant delay.Subsequent to the initially filed report, additional information was provided.The tip of the delivery catheter was noted to be bent during attempts to load the emboshield nav 6 filter.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection, functional testing, and dimensional analysis was performed on the returned device.The reported difficult to insert was unable to be confirmed with the returned delivery catheter due to the damage noted.However, the filter was loaded into a proxy delivery catheter with no resistance noted, indicating that the filtration element functioned properly.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.The investigation was unable to determine a definitive cause for the reported difficulties.It is possible that the filter was pulled into the pod too quickly or with excessive force causing damage to the delivery catheter pod preventing the filtration element from being able to load properly; however, this could not be confirmed.Based on the reported information and evaluation of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 correction: medical device problem code 1069 removed and code 2889 added.

• 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: 20830670
• Report Number: 2024168-2024-14181
• Device Sequence Number: 15612915
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)260430(10)3050461
• 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): 01/13/2025

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 Expiration Date: 04/30/2026
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 3050461
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/21/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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