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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 Difficult to Remove (1528); Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 01/03/2014
Event Type  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. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Subsequent venogram revealed, showing the tip of the sheath to be within the inferior vena cava above the iliac veins and below the renals. The first ivc filter was then brought to the field but there was difficulty in passing it through the initial portion of the sheath. Once it was passed, it was advanced, but the tip of the sheath had been moved into the right iliac vein. The sheath was inadvertently pulled back with the filter exposed, deploying the filter in the right iliac vein. An attempt was made to pass the cook down to engage the top of the ivc filter and extracted but could not get the scope to engage. As a result, elected to leave the filter in place. The sheath was then pulled back to the third lumbar vertebrae. Approximately four years post filter deployment, patient scheduled for filter removal. Both the filters were removed without any difficult. Therefore, the investigation is confirmed for the positioning issue, retrieval difficulties and difficult to advance. However, the investigation is inconclusive for perforation of the ivc. Based upon the available information, 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. (expiry date: 11/2016), (b)(4).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, it was alleged that the filter struts perforated into the organs. The device was removed percutaneously. The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.

 
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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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9804855
MDR Text Key182626859
Report Number2020394-2020-01343
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDL900J
Device Catalogue NumberDL900J
Device LOT NumberGFXK0019
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2013
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: 03/09/2020 Patient Sequence Number: 1
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