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

Model Number DL900F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976); Positioning Problem (3009)

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 will not be performed.The device was not returned for evaluation, however medical records were provided and reviewed.Therefore, the investigation is confirmed for the alleged filter tilt, material deformation, positioning issue and retrieval difficulties.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 dl900f vena cava filter allegedly experienced tilt, material deformation, positioning issue and difficult to be removed.This information was received from one source.One patient was involved with no reported patient injury.The male patient is (b)(6) years old and weight was not provided.

• 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 NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12191561
• MDR Text Key: 262488320
• Report Number: 2020394-2021-80584
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• 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: 07/19/2021

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 Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/19/2021
• Type of Device Usage: N
• Patient Sequence Number: 1