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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number DL950J
Device Problems Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the denali jugular system that are cleared in the us. The pro code and 510 k number for the denali jugular system are identified. As the lot number for the device was provided, a review of the device history records will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. (expiry date: 01/2024). Device not returned.
 
Event Description
It was reported that during vena cava filter placement, the sheath was allegedly unable to be inserted and the filter was deformed. It was further reported that another device was used to complete the procedure. There was no reported patient injury.
 
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Brand NameDENALI JUGULAR 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 Key12665869
MDR Text Key277453495
Report Number2020394-2021-01896
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDL950J
Device Lot NumberGFFP0433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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