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

Catalog Number 22438-19

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the carotid artery with heavy calcification and heavy tortuosity.The emboshield nav6 embolic protection filter was prepped, advanced and deployed.When the physician wanted to remove the sheath [delivery catheter], it was stuck and could not be removed.Therefore, the whole emboshield nav6 eps was removed without issue.A new emboshield nav6 eps was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported difficulty to remove was unable to be confirmed due to the condition of the returned device.However, the guidewire exit port was noted to be torn, stretched and jagged which likely contributed to the difficulty removing the delivery catheter.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.The investigation determined that the reported difficulty was due to procedural related circumstances.It is likely that during use the clearance between the inner diameter of the delivery catheter and outer diameter of the barewire was reduced, likely due to anatomical conditions, resulting in difficulty removing the delivery catheter due to the barewire tearing into the guidewire exit port of the delivery catheter during the attempt to remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat the carotid artery with heavy calcification and heavy tortuosity.The emboshield nav6 embolic protection filter was prepped, advanced and deployed.When the physician wanted to remove the sheath [delivery catheter], it was stuck and could not be removed.Therefore, the whole emboshield nav6 eps was removed without issue.A new emboshield nav6 eps was used to complete the procedure.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 EMBOLIC PROTECTION SYSTEM
• Type of Device: 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: 17711772
• MDR Text Key: 322972878
• Report Number: 2024168-2023-09779
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22438-19
• Device Lot Number: 3032962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EMBOSHIELD NAV 6 DELIVERY CATHETER.
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic