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

Model Number DL900F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned for evaluation, however medical records were provided.Based on medical record review, the investigation is confirmed for detachment.However, the investigation is inconclusive for tilt.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 indicates that model dl900f vena cava filter allegedly experienced tilt and detachment.The information was received from a single source.This malfunction involved one patient with no patient consequences.The (b)(6) year old female patient was (b)(6) lbs.

• 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: 12192945
• MDR Text Key: 262488499
• Report Number: 2020394-2021-80586
• 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

• Date FDA Received: 07/19/2021
• 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: GFYD3220
• Date Manufacturer Received: 06/30/2021
• Type of Device Usage: N
• Patient Sequence Number: 1