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

Catalog Number DL950J

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in 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.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 denali jugular delivery system kit was returned for evaluation.During visual evaluation, the filter was noted to be in the storage tube.The filter hook was noted to be dislodged from the pusher gripper within the storage tube.The pusher catheter was used to push the filter outside the storage tube.Three electronic photos were provided and reviewed.The first photo shows the introducer sheath, pusher catheter, and dilator.The pusher catheter was connected to the touhy adapter and filter storage tube.The filter was noted to be within the storage tube.The second and third photo shows the filter and filter storage tube.The filter hook was noted to be dislodged from the pusher gripper.Therefore, based on the photo review, the reported failure to advance the issue is can be confirmed.The identified device dislodged or dislocated issue also can be confirmed.Therefore, the investigation is confirmed for the reported failure to advance as the filter was noted to be in the storage tube.The investigation is also confirmed for the identified device dislodged as the filter hook was noted to be dislodged from the pusher gripper.A definitive root cause for the reported failure to advance and identified device dislodged issues 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.

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.

• 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: 16129203
• MDR Text Key: 308648926
• Report Number: 2020394-2022-01058
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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