MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number	22437-19
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the emboshield nav6 embolic protection system (eps), during shaping, the coils of the barewire were noted to be stretched.The core and coils were intact.The device was not used and there was no patient involvement.Another emboshield nav6 eps was prepared and when the barewire was being shaped, it was found that the coils of the barewire were noted to be stretched.The core and coils were intact.Additionally, the delivery catheter of the second emboshield nav6 was separated during the process of packing the device for return.The device was not used and there was no patient involvement.A third emboshield nav6 eps was used to complete the procedure.There was no clinically significant delay in the procedure.Returned device analysis identified that both devices had separated tip coils and the core was separated and a portion was not returned.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned product.The reported difficulty shaping the tip was unable to be tested due to device condition.The stretched/separated tip coils were confirmed.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.Based on the reported event description and evaluation of the returned unit, the reported difficulty shaping the tip and damage to the tip coils was due to inadvertent user mishandling during the attempt to shape the tip.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional emboshield nav6 embolic protection system (eps) device referenced in b5 is filed under a separate medwatch report number.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Common Device Name: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 19262819
• Report Number: 2024168-2024-05586
• Device Sequence Number: 6492819
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)260531(10)3061961
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141678
• 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): 05/07/2024

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: 05/31/2026
• Device Catalogue Number: 22437-19
• Device Lot Number: 3061961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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