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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER Back to Search Results
Model Number DL900F
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the reported malfunction was not provided, therefore, a lot history review will not be performed.The device was not returned for evaluation, however medical records were provided and reviewed.Therefore, the investigation is confirmed for filter migration.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicates that model dl900f vena cava filter allegedly migrated.The information was received from a single source.One patient was involved with no reported patient injury.The male patient is (b)(6) and weighs was not provided.
 
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Brand Name
DENALI FEMORAL SYSTEM
Type of Device
VENA 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 Key11205410
MDR Text Key227926722
Report Number2020394-2021-80022
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040801
UDI-Public(01)00801741040801
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 01/20/2021
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 Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 12/31/2020
Initial Date FDA Received01/20/2021
Type of Device Usage N
Patient Sequence Number1
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