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

Catalog Number DL950F

Device Problems 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 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one femoral denali filter kit for evaluation.The pusher catheter arrived loaded into the touhy-borst adapter and the filter storage tube.Upon visual evaluation, a complete detachment was noted on the distal end of the introducer sheath.The distal tip of the dilator was noted to be deformed.Skiving was noted throughout the filter storage tube.Further under x-ray examination, the filter was noted to be seated proximal to the introducer sheath hub.Upon functional testing, an in-house mandrel was used to deploy the filter from the introducer sheath hub.Resistance was felt during test, but the filter deployed successfully.The filter limbs were present and uncrossed.The remaining portion of the pusher wire was also deployed.One electronic photo was provided and reviewed.The photo shows a femoral denali filter kit with blood residue in which a complete detachment was noted to the introducer sheath.No other visual anomalies were noted.Therefore, based on the photo review, the identified detachment issue can be confirmed.Therefore, the investigation is confirmed for the reported failure to advance as the filter was returned seated proximal to the introducer sheath hub and resistance was felt during deployment.The investigation is confirmed for the identified deformation due to compressive stress and identified detachment issue as the dilator distal tip noted to be deformed and a complete detachment was noted on the distal end of the introducer sheath.A definitive root cause for the reported failure to advance and identified detachment of device or device component and deformation due to compressive stress 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.(expiration date: 03/2026) 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 Description

It was reported that during an inferior vena cava filter placement procedure via right femoral vein, the filter was allegedly stuck and cannot continue to be transported.The procedure was completed 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 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: 18919851
• MDR Text Key: 337847244
• Report Number: 2020394-2024-00348
• 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: 03/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: DL950F
• Device Lot Number: GFHR0474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/18/2024
• 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