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	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous inferior vena cava filter implantation using a denali filter.During the procedure, filter allegedly deployed prematurely inside the sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device was returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one electronic photo was provided and reviewed.The photos show a package, inside the package one pusher catheter loaded into touhy-borst adapter loaded onto a filter storage tube, loaded into an introducer sheath were visible.No other anomalies were observed.One filter kit was received.On visual evaluation, the kit included one pusher catheter loaded into touhy-borst adapter loaded onto a filter storage tube, loaded into an introducer sheath and one deployed filter.Sample appeared to have residue throughout.The filter was observed to be deployed with a caudal leg and long leg crossed.No other anomalies were observed.On functional testing, an attempt to retract the loaded pusher catheter from the touhy-borst adapter, filter storage tube and introducer sheath was performed and was successful.The pusher catheter was noted to have blood residue throughout.The flat end/pusher pad were present on the distal end of the pusher catheter.The touhy-borst adapter and the filter storage tube were offloaded from the introducer sheath for further evaluation.No anomalies were observed throughout the touhy-borst adapter.What appeared to be blood residue, was noted within the filter storage tube.Slight skiving was noted throughout the filter storage tube.The introducer sheath showed signs of curvature.No anomalies were noted to the distal end.Therefore, the investigation is inconclusive for the reported premature activation as the conditions of use cannot be recreated.A definitive root cause for the reported premature activation could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (method, result, conclusion).Section a through f: the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous inferior vena cava filter implantation using a denali filter.During the procedure, the filter allegedly deployed prematurely inside the sheath.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23954734
• Report Number: 2020394-2025-02311
• Device Sequence Number: 21191559
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795(17)280728(10)GFKU0092
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: GFKU0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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