MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Denali Jugular System; Vena Cava Filter

Catalog Number	DL900J
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a percutaneous inferior vena cava filter implantation via the jugular vein using a denali filter.During the procedure, the filter was allegedly deployed prematurely.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: Denali Jugular System
• Common Device Name: Vena Cava Filter
• Manufacturer (Section D): Bard Peripheral Vascular, Inc.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. Bard, Inc. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50114814
• Report Number: 2020394-2026-02005
• Device Sequence Number: 17469141
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795(17)290428(10)GFLR1266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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 Catalogue Number: DL900J
• Device Lot Number: GFLR1266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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