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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FILTER VENA CAVA FILTER Back to Search Results
Catalog Number DL950F
Device Problems Positioning Failure (1158); Failure to Advance (2524); Activation, Positioning or SeparationProblem (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.

 
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Brand NameDENALI FILTER
Type of DeviceVENA 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 Key9215384
MDR Text Key163054238
Report Number2020394-2019-04167
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberDL950F
Device LOT NumberGFBY0537
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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