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

Model Number DL900J

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl900j.Vena cava filter allegedly experienced migration of device or device component, and patient device interaction problem.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for evaluation, however medical records were provided.Confirmed for difficult to deploy and filter migration.However, the investigation is inconclusive for patient device interaction problem.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4 h11: b5, h6 (device code, results, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl900j.Vena cava filter allegedly experienced migration of device or device component, and patient device interaction problem.This report was received from a single source.This event did involve patient with no reported patient injury.The 20 year old female weighed 149 lbs.

• Brand Name: DENALI FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9214946
• MDR Text Key: 163041008
• Report Number: 2020394-2019-04152
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFZC3117
• Date Manufacturer Received: 03/31/2020
• Patient Sequence Number: 1