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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER Back to Search Results
Catalog Number DL950F
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.
 
Event Description
It was reported that during ivc filter deployment, the filter was allegedly difficult to advance into the lesion and resistance was felt.It was further reported upon removal, the filter was allegedly seemed twisted within the system.There was no reported patient injury.
 
Event Description
It was reported that during ivc filter deployment, the filter was allegedly difficult to advance into the lesion and resistance was felt.It was further reported upon removal, the filter was allegedly seemed twisted within the system.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one denali femoral delivery device was returned for evaluation.Three photos were provided and reviewed.Evaluation of the device and photos reveal a filter inside the storage tube with pusher wire detached from the filter.The filter was removed from the storage tube using a mandrel.All limbs were present and uncrossed.Therefore, the investigation can be confirmed for failure to advance and detached pusher wire.However, the investigation is inconclusive for twisted limbs as it is unknown whether any significant twisting of the limbs occurred inside the storage tube.Per the provided event details, the filter was retracted into the deliver system and then reintroduced following an initial attempt to insert the filter from the storage tube.The current ifu (instructions for use) states, "loosen the proximal end of the touhy-borst adapter and advance the filter through the introducer sheath by moving the pusher forward.Do not twist or retract the pusher at any time during the procedure." it is possible that the reintroducing of the filter resulted in twisting of the filter limbs and the detached pusher wire.However, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.The current ifu (instructions for use) states: -loosen the proximal end of the touhy-borst adapter and advance the filter through the introducer sheath by moving the pusher forward.Do not twist or retract the pusher at any time during the procedure.Expiry date 01/2021.
 
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Brand Name
DENALI VENA CAVA FILTER
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8090088
MDR Text Key127909143
Report Number2020394-2018-02093
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040825
UDI-Public(01)00801741040825
Combination Product (y/n)N
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDL950F
Device Lot NumberGFBZ0817
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Initial Date Manufacturer Received 10/31/2018
Initial Date FDA Received11/20/2018
Supplement Dates Manufacturer Received02/25/2019
Supplement Dates FDA Received02/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
Patient Weight65
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