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

Model Number	22437-19
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Lot history record (lhr) and corrective and preventive 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 emboshield nav6 instruction for use (eifu), ¿do not attempt to move the filtration element after deployment and prior to the start of retrieval.¿ based on the reported information, there was no device issue reported with the emboshield nav6 device.Based on the reported information, the reported difficulties appear to be due to inadvertent retraction of the barewire during the procedure causing the filter to move down the carotid artery.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional device referenced in b5 is filed under a separate medwatch report number.H6: medical device problem code 2017 - incorrect removal.
Event or Problem Description
It was reported that the procedure was to treat the carotid artery.The first emboshield nav6 embolic protection system (eps) was advanced to the lesion and deployed.During the procedure the tech accidentally pulled on the barewire, moving the filter down the carotid artery.The filter was recaptured and removed and a new emboshield nav6 eps filter was deployed.At the end of the procedure it was found that the retrieval catheter had been discarded so a non-abbott catheter was used to capture the filter and remove it from the anatomy.There were no adverse patient effects and there was no clinically significant delay 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: 20402461
• Report Number: 2024168-2024-11888
• Device Sequence Number: 3351080
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)251130(10)2121961
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 2121961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2022
• 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