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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
Model Number DL900J
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided for ten of the sixteen reported malfunctions; therefore, a lot history review could be performed.The sample was not returned to the manufacturer for evaluation; however medical records has been provided and reviewed for all the malfunctions.For 15 of the 16 malfunctions, the investigation is confirmed for perforation.The remaining one malfunction is inconclusive for perforation.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.(gfyc1449, gfxh2817, gfxc2658, gfxd3899, gfau0077, gfbx1614, gfxi2541, unknown).
 
Event Description
This report summarizes sixteen malfunctions.A review of the reported information indicated that model dl900j vena cava filter allegedly experienced perforation.This information was received from various sources.This malfunctions involved patients with no consequences.Of the sixteen reported patients, their ages ranged from 54 ¿ 86 years and 9 were female and 6 were male.Three of the patient's weights ranged from 154 - 360 pounds.The remaining patients' weights were not provided.
 
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Brand Name
DENALI FILTER
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 Key10308585
MDR Text Key199886538
Report Number2020394-2020-04900
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040795
UDI-Public(01)00801741040795
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 07/22/2020
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 Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFYL3401, GFXK0021, GFYF3842
Initial Date Manufacturer Received 06/30/2020
Initial Date FDA Received07/22/2020
Type of Device Usage N
Patient Sequence Number1
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