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

Catalog Number DL950F

Device Problems Positioning Failure (1158); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the denali filter products that are cleared in the us.The pro code and 510k number for the denali filter products is identified in d2 and g4.H10: 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 denali femoral delivery system kit was received for evaluation.The filter storage arrived loaded on to the introducer sheath.Skiving was noted throughout the filter storage tube.The distal tip of the dilator was noted to be deformed.No pusher wire was noted on the distal end of the pusher catheter.No anomalies were noted to the touhy-borst adapter.Under x-ray examination, the filter was noted to be seated distal to the distal end of the introducer sheath.An in-house mandrel was used to deploy the filter from the introducer sheath.Resistance was felt during the test but the filter was deployed successfully.All filter limbs were present and uncrossed.Remaining portion of the pusher wire was not deployed.Also, one photo was reviewed.The photo shows the dilator, introducer sheath and pusher catheter of the denali femoral kit.The pusher wire cannot be seen at the distal end of the pusher catheter.Therefore, the investigation is confirmed for the reported failure to advance as resistance was felt during deployment of the filter from the introducer sheath.However, the investigation is inconclusive for the reported failure to deploy as the filter advancement issue might have led to the deployment issue.The investigation is also confirmed for the identified pusher wire detachment as the device was received with the pusher wire completely detached.The investigation is also confirmed for the identified distal tip deformation as the distal tip of the dilator was noted to be deformed.A definitive root cause for the reported failure to advance, failure to deploy, identified pusher wire detachment and distal tip deformation 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.H10: d4 (expiry date: 05/2026).H11: 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.H3 other text : see h10.

Event Description

It was reported that during an inferior vena cava filter placement procedure through the left femoral vein approach, the filter allegedly failed to be pushed out.It was further reported that there were difficulties and resistance to advance the filter.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: 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: 19189282
• MDR Text Key: 341559742
• Report Number: 2020394-2024-00571
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040825
• UDI-Public: (01)00801741040825
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DL950F
• Device Lot Number: GFHS0989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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