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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
Model Number DL900J
Device Problems Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2018
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 device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 04/2021).
 
Event Description
It was reported that during a vena cava filter deployment, the filter was allegedly partially deployed in an improper position.It was reported that another filter was used to complete the procedure.There was no patient involvement.
 
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:the device was returned for evaluation.Images were not provided.The investigation is inconclusive for the reported deployment issue as the storage tube and filter were not returned and no images were provided to reveal poor positioning of the filter.Per the reported event details, the filter may have deployed prematurely.This could have resulted in improperly positioning of the filter.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.
 
Event Description
It was reported that during a vena cava filter deployment, the filter was allegedly partially deployed in an improper position.It was reported that another filter was used to complete the procedure.There was no patient involvement.
 
Event Description
It was reported that during a vena cava filter deployment, the filter was allegedly partially deployed in an improper position.It was reported that another filter was used to complete the procedure.There was no patient involvement.
 
Manufacturer Narrative
H10: 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:the device was returned for evaluation.Images were not provided.The investigation is inconclusive for the reported deployment issue as the storage tube and filter were not returned and no images were provided to reveal poor positioning of the filter.Per the reported event details, the filter may have deployed prematurely.This could have resulted in improperly positioning of the filter.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.H11: h3, h6 (results, conclusion).H11:section a through f - the information provided by bard 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 bard.
 
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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 Key8082008
MDR Text Key127575120
Report Number2020394-2018-02046
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040795
UDI-Public(01)00801741040795
Combination Product (y/n)N
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
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 NumberGFCR0493
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2018
Date Manufacturer Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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