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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 Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2022
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified in section d4 has not been cleared in the us but is similar to the the denali filter system that are cleared in the us.The pro code and 510 k number for the denali filter system are identified in d2 and g4.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: 04/2025).
 
Event Description
It was reported that during vena cava filter placement via the right internal jugular vein, the guidewire allegedly difficult to advance.It was further reported the tip of the sheath allegedly migrated and the filter was expanded in the iliolumbar vein during insertion.Reportedly, the filter was removed by a snare.The procedure was completed by using same device.There was no reported patient injury.
 
Event Description
It was reported that during vena cava filter placement via the right internal jugular vein, the guidewire allegedly difficult to advance.It was further reported the tip of the sheath allegedly migrated and the filter was expanded in the iliolumbar vein during insertion.Reportedly, the filter was removed by a snare.The procedure was completed by using same device.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the the denali filter system that are cleared in the us.The pro code and 510 k number for the denali filter system are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one jugular delivery system kit was returned for evaluation.During visual evaluation, there is no visual anomaly noted to the dilator.Therefore, the investigation is remains inconclusive for the difficult to advance and activation, positioning or separation problem issue as there is no clear evidence.A definitive root cause for the alleged difficult to advance, and activation, positioning or separation problem could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2025),.
 
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Brand Name
DENALI JUGULAR SYSTEM
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 12804
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key15948307
MDR Text Key307932053
Report Number2020394-2022-00971
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040818
UDI-Public(01)00801741040818
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 Physician
Type of Report Initial,Followup
Report Date 01/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDL950J
Device Lot NumberGFGR1179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2023
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
Patient Sequence Number1
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