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

Catalog Number DL950J

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 09/20/2022

Event Type  malfunction  

Event Description

It was reported that prior to a vena cava filter placement procedure the filter was allegedly failed to advance.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

The catalog number identified in catalog# 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 pma/510k.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: the device was not returned for evaluation.Two electronic photos were provided and reviewed.The first photo shows the pusher catheter, one dilator, and two introducer sheaths.One is a femoral introducer sheath (green) and the other is a jugular introducer sheath (white).The jugular introducer sheath was broken into two segments.The pusher catheter was inserted into the storage tube.The pusher catheter was noted to be kinked.The second photo shows the partially visible introducer sheath (jugular) and pusher catheter(jugular).Therefore, the investigation remains inconclusive for the failure to advance the issue.The investigation is confirmed for the material deformation issue as the pusher catheter was noted to be kinked.The investigation is also confirmed for the detachment issue as the introducer sheath was noted to be broken into two segments.A definitive root cause for the reported failure to advance and identified material deformation and detachment issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 02/2025).

• Brand Name: DENALI JUGULAR 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: 16231546
• MDR Text Key: 309158913
• Report Number: 2020394-2022-01083
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• 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: 12/31/2022

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: DL950J
• Device Lot Number: GFGP0315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2022
• 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