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); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 70% stenosed de novo lesion in the internal carotid artery.The barewire of the small emboshield nav6 embolic protection system (eps) was advanced with difficulty due to resistance with the guide catheter.Then the eps was removed from the patient and the barewire was noted to become unraveled [break and stretched].Therefore, another emboshield eps device was used to continue with the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stretched coils and break were confirmed.The reported difficulty advancing could not be confirmed as it was related to procedural circumstances.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 number specific issue.The investigation determined that the reported difficulties were due to circumstances of the procedure.It is likely that during advancement, the barewire tip became compromised due to resistance with the guide catheter resulting in stretched tip coils and break of the barewire core.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: 22331181
• Report Number: 2024168-2025-06464
• Device Sequence Number: 15593551
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)270630(10)4072961
• 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
• Report Date (Section B): 06/25/2025

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: 4072961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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