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

Model Number DL900J

Device Problems Complete Blockage (1094); Difficult to Remove (1528); Material Deformation (2976)

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

Event Type  malfunction  

Event Description

A review of the reported information indicated that model dl900j vena cava filter experienced material deformation, occlusion and difficult to remove.The information was received from a one source.This malfunction involved one patient with no patient consequences.The (b)(6) male patient weighs (b)(6).

Manufacturer Narrative

The lot number for the device was not provided, therefore a lot history review could not be performed.The device was not returned for evaluation.Medical record was provided and reviewed.Therefore, the investigation is confirmed for occlusion, material deformation and difficult to remove.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.

• 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 NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13302655
• MDR Text Key: 284294074
• Report Number: 2020394-2022-90048
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/31/2021
• Type of Device Usage: A
• Patient Sequence Number: 1