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

Catalog Number UNK DENALI

Device Problems Malposition of Device (2616); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was not provided, therefore, a lot history review cloud not be performed.The device was not returned for evaluation, however medical records were provided and reviewed.Therefore, the investigation is confirmed for tilt and material deformation.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

A review of the reported information indicated that model unk denali vena cava filter experienced tilt and material deformation.The information was received from a one source.This malfunction involved one patient with no patient consequences.The male patient is (b)(6) years old.Weight of the patient was not provided.

• Brand Name: DENALI FILTER 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: 11694730
• MDR Text Key: 246467616
• Report Number: 2020394-2021-80337
• Device Sequence Number: 1
• Product Code: DTK
• 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: 04/20/2021

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: No Information
• Device Catalogue Number: UNK DENALI
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/20/2021
• Type of Device Usage: N
• Patient Sequence Number: 1