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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 Difficult to Insert (1316); Failure to Advance (2524); Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2021
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 is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 02/2024).
 
Event Description
It was reported that during vena cava filter placement via the internal jugular vein, the vena cava filter was allegedly unable to insert through the sheath and the filter was allegedly deformed. It was further reported that another device was used to complete 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 Key12493974
MDR Text Key272114428
Report Number2020394-2021-01754
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDL950J
Device Lot NumberGFFQ0658
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
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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