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

Catalog Number DL950F

Device Problems Positioning Failure (1158); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation.The company is still investigating the issue.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl950f vena cava filter allegedly experienced failure to deploy, partial deployment, and material deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dl950f vena cava filter allegedly experienced failure to deploy, failure to advance, and detachment.This information was received from one source.The malfunction did not involve a patient.The patient¿s age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation.The evaluation is confirmed for failure to advance and detachment, but is unconfirmed for failure to deploy.A definite root cause cannot be determined.The device is labeled for single use.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.

• 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: 9215384
• MDR Text Key: 163054238
• Report Number: 2020394-2019-04167
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040825
• UDI-Public: (01)00801741040825
• 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: 03/30/2020

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: DL950F
• Device Lot Number: GFBY0537
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/01/2020
• Patient Sequence Number: 1