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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 Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

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 vena cava filter products are identified. As the lot number for the device was provided, a device history review was performed. One denali filter, storage tube and a pusher catheter were returned to the manufacturer for inspection/evaluation. Investigation of the returned device confirmed advancement failure, detachment issue and kink. Based upon the available information, the definitive root cause for this event is unknown. 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 advance, material deformation and detachment. This information was received from one source. Of the one malfunction, one patient was involved with no patient consequence or impact. The age, weight and gender of the patient was 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 Key10298483
MDR Text Key199655423
Report Number2020394-2020-04667
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 07/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberDL950F
Device LOT NumberGFDQ3901
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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