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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 DL900J
Device Problems Material Twisted/Bent (2981); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2015
Event Type  malfunction  
Manufacturer Narrative
No device and no medical records have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. One image was provided and review is currently underway. The investigation of the reported event is currently underway. 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.
 
Event Description
It was reported that during a jugular vena cava filter deployment procedure, the filter legs allegedly became tangled and the filter failed to expand despite multiple attempts to manually expand the filter. The filter was captured, retrieved and another jugular vena cava filter was prepped and deployed successfully. There was no reported impact or consequence to the patient.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the 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 failure mode. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: failure to expand can be confirmed based on the image provided as the filter legs were crossed at the caudal anchors. Conclusion: the device was not returned, however one image was provided. Failure to expand can be confirmed based on the images provided as the filter legs were crossed at the caudal anchors. Based upon the available information, the definitive root cause for this event is unknown. It is unknown if procedural factors contributed to the reported event. Labeling review: the current ifu (instructions for use) states: warning: delivery of the denali filter through the introducer sheath is advance only. Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath. If large thrombus is demonstrated at the initial delivery site, do not attempt to deliver the filter through it as migration of the clot and/or filter may occur. Attempt filter delivery through an alternate site. A small thrombus may be bypassed by the guidewire and introducer sheath. Precautions: do not deliver the filter by pushing it beyond the end of the introducer sheath. To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath. Do not twist the pusher at anytime during this procedure. Potential complications: failure of filter expansion/incomplete expansion 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 NameDENALI JUGULAR SYSTEM
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5369943
MDR Text Key36084523
Report Number2020394-2015-02120
Device Sequence Number1
Product Code DTK
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue NumberDL900J
Device Lot NumberGFZI0366
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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