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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
Catalog Number DL950F
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. However, photo, images and videos were provided for review. The investigation of the reported event is currently underway. The catalog number identified in section has not been cleared in the us but is similar to the denali femoral system products that are cleared in the us. The pro code and 510k number for the denali femoral system products is identified. (expiry date: 04/2023).
 
Event Description
It was reported that after the filter removal procedure, the leg wire allegedly detached inside the superior vena cava. There was no reported patient injury.
 
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Brand NameDENALI FEMORAL SYSTEM
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 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11853830
MDR Text Key251653238
Report Number2020394-2021-01070
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDL950F
Device Lot NumberGFER2553
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/20/2021 Patient Sequence Number: 1
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