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

Catalog Number DL950F

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported that during a filter placement procedure, the propeller allegedly could not be advanced.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified in common device name and premarket identification.Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one femoral denali filter kit was returned for evaluation.Filter was in storage tube partially exposed from the proximal end of the filter and was noted to be bent.Skiving to the storage tube due to deployment of the filter, no bowing noticed.The pusher wire noted to be detached from the pusher catheter.Although, the sample was returned one electronic video was provided and reviewed, the video shows, during filter advancement to the patient, the filter was allegedly struck within the storage tube.Based on the findings, the investigation is confirmed for the reported failure to advance, identified pusher wire detachment and filter deformation issues.A definitive root cause for the reported failure to advance, identified pusher wire detachment and filter deformation issues could not be determined based upon the provided information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 02/2025).

• 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: 16041249
• MDR Text Key: 308352227
• Report Number: 2020394-2022-01006
• Device Sequence Number: 1
• Product Code: DTK
• 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: 11/28/2022

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: GFGP0973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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