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

Catalog Number 22437-19

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that during preparation of the emboshield nav 6 embolic protection system (eps), the short barewire was exchanged for the longer 300cm barewire when the delivery catheter was found to be broken near the radiopaque marker.The device was not in two pieces nor used.Another eps was used to complete the procedure.There was no patient involvement and 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 device.The reported damage to the delivery catheter pod was 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.The investigation determined that the reported damage to the delivery catheter pod occurred during exchange of the barewire to the longer 300cm length.There was no damage noted prior to preparation indicating that the damage was not pre-existing.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: medical device problem code1069 was removed and replaced with 2981.

Event Description

Subsequent to the initially filed mdr report, returned device analysis noted that the delivery catheter (dc) pod was wrinkled, but not broken as originally reported.Additional follow up with the site indicates that the correct device was returned and what was considered as "broken", actually means wrinkled.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: 18926491
• MDR Text Key: 337944409
• Report Number: 2024168-2024-03454
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)261031(10)3111661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 22437-19
• Device Lot Number: 3111661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• 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