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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
Model Number DL900J
Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/22/2022
Event Type  malfunction  
Event Description
It was reported that during a vena cava filter placement procedure at the internal jugular vein, the filter allegedly had deployment issue.The procedure was completed by another device.There was no reported patient injury.
 
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 03/2025).
 
Event Description
It was reported that during a vena cava filter placement procedure at the internal jugular vein, the filter allegedly had deployment issue.The procedure was completed by another device.There was no reported patient injury.
 
Manufacturer Narrative
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 denali filter kit has been returned for evaluation.While receiving, the pusher catheter was loaded into the touhy adaptor and filter storage tube.The filter was inside the storage tube.The filter hook remained connected to the pusher gripper.Due to an advancement issue, skiving was observed in the storage tube.Therefore, the investigation is confirmed the filter advancement issue, as the filter was received inside the storage and skiving was observed to the storage tube.However, the investigation for the deployment issue is inconclusive as the filter was received inside the storage tube and there was no clear evidence provided to confirm the reported event.A definitive root cause for the reported deployment and identified advancement issues 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: 03/2025), g3, h6(device, method) h11; h6(result, conclusion) h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
 
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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 Key14904936
MDR Text Key295234449
Report Number2020394-2022-00532
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040795
UDI-Public(01)00801741040795
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFGQ0180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/25/2022
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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