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

Catalog Number	DL900F
Medical Device Problem Codes	Positioning Failure (1158); 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	07/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one denali femoral filter kits were received for evaluation.The kit included one pusher catheter, touhy borst adapter loaded onto a filter storage tube and an introducer sheath loaded onto the distal end of the filter storage tube and a dilator.The filter was not returned.Upon visual inspection the complaint sample appeared to have blood residue throughout.The distal end of the sheath was observed to be cut, and the distal segment was not returned.The distal tip of the dilator was observed to be deformed.The pusher catheter was noted to be pushed within the loaded devices.Functional testing an attempt to advance loaded pusher catheter throughout the loaded devices (touhy-borst adapter, filter storage tube and introducer sheath) was performed and small resistance was felt.Filter was noted within the introducer sheath.The attempt was successful when the filter deployed from the distal end of the introducer sheath.Filter limbs were present, and no legs were noted to be crossed.What appeared to be blood tissue, was noted throughout the filter legs.The pusher catheter was offloaded from the touhy-borst adapter, filter storage tube and introducer sheath without issue.No anomalies were noted to the pusher wire.The touhy-borst adapter and the filter storage tube was offloaded from the introducer sheath for further evaluation.The touhy-borst adapter was offloaded from the filter storage tube.Slight skiving was noted throughout the filter storage tube.The distal catheter segment was not returned.Therefore, the investigation is inconclusive for the reported positioning failure as the conditions during use cannot be recreated.Investigation is identified and confirmed for the deformation due to compressive stress as the distal tip of the dilator was noted to be deformed.Investigation is identified and confirmed for the detachment as the distal end of the sheath was observed to be cut.A definitive root cause for the reported positioning failure and identified deformation due to compressive stress and detachment 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.Section a through f: the information provided by bd represents all 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 87-year-old male patient underwent an inferior vena cava filter placement procedure in right femoral groin vein for deep vein thrombosis.During the procedure the filter allegedly did not deploy 2x same pt.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: DENALI FEMORAL 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: 23602912
• Report Number: 2020394-2025-01915
• Device Sequence Number: 21294126
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801(11)250531(17)280531(10)GFKR1240
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2025

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: DL900F
• Device Lot Number: GFKR1240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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 Age: 87 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic