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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); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
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 in procode and pma/510k. 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: 10/2023).

 
Event Description

It was reported that prior to a filter placement, the device was allegedly difficult to advance and the hook was separated within the sheath. It was further reported that the physician removed the whole system and deployed another filter. There was no patient contact.

 
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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 Key12194379
MDR Text Key262471318
Report Number2020394-2021-01347
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDL950J
Device LOT NumberGFEX1266
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/16/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated By Manufacturer? No
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: 07/20/2021 Patient Sequence Number: 1
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