MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM; VENA CAVA FILTER

Catalog Number	DL900J
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
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 jugular denali introducer sheath was received for evaluation.Upon visual inspection, it was noted a partial introducer sheath was returned.The sample was bloody along with the tubing connected to the cock stop.On functional testing an in-house dilator could not be advanced due to a blockage approximately 1.1 cm from the hub¿s proximal end.A portion of the sheath was cut to inspect the distal end, but nothing was visible.After flushing, a small metal piece was expelled.Microscopic examination revealed another metal piece inside the hub, identified as crushed marker bands from the dilator used during the procedure.Attempts to remove the remaining metal piece with a mandril were unsuccessful, and no further functional testing was done.Therefore, the investigation is confirmed for the reported failure to advance as the damage seen, were not able to advance, and the detached components were noted.However, the investigation is identified and confirmed for the detachment of device or device component as the partial introducer sheath has been received and marker band detached from the dilator.Investigation is identified and confirmed for the deformation due to compressive stress as the distal tip of the dilator was observed to be deformed.A definitive root cause for the reported failure to advance, identified detachment could not be determined since it is not known if the marker band detached causing the advancement issues, or if advancing was not possible due to another factor and caused the marker band detachment and identified deformation due to compressive stress.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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, prior to an percutaneous inferior vena cava filter implantation procedure using the denali filter, the sheath was faulty and the filter allegedly could not load in properly.The procedure was completed using another device.There was no reported patient injury.Further, detachment and deformation was recorded.

• 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: 23567809
• Report Number: 2020394-2025-01889
• Device Sequence Number: 15919863
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795(17)280531(10)GFKR0252
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 11/13/2025

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: GFKR0252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/17/2025
• 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