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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 Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number was not provided for both malfunctions, therefore, a lot history review was not performed. The samples were not returned to the manufacturer for inspection/evaluation. For one of the two malfunctions, medical records were provided and reviewed. The investigation is inconclusive for the alleged retrieval difficulties. Medical records were not provided for the second malfunction; therefore, the investigation is inconclusive for the alleged retrieval difficulties as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based on the available information, the definitive root cause is unknown. The devices are labeled for single use. For one malfunction, the catalog number identified has not been cleared in the u. S. But, it is similar to the denali vena cava filter products that are cleared in the us. The pro code for the denali vena cava filter products is identified.

 
Event Description

This report summarizes two malfunctions. A review of the reported information indicates that model dl950f vena cava filter allegedly experienced difficult to remove. The information was received from multiple sources. Of the two malfunctions, both involved patients with no patient consequences. Age, weight, and gender were not provided for both patients.

 
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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 Key10314560
MDR Text Key200204529
Report Number2020394-2020-05001
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
Report Date 07/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberDL950F
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
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

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