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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 Device Operates Differently Than Expected (2913); Activation Failure (3270)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2015
Event Type  Malfunction  
Manufacturer Narrative

No device, no medical records and no medical images 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. 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 vena cava filter deployment several legs were allegedly crossed. The surgeon reportedly decided to leave the filter in place. 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, 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 event reported to date for this lot number and 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: no medical images have been made available to the manufacturer. Conclusion: neither the device nor images were provided. The investigation is inconclusive for crossed legs upon deployment. Per the reported event, the physician pulled back on the pusher prior to deployment. Per the instructions for use (ifu), "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. " therefore, it is possible that the physician's deployment technique contributed to the reported event. However, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings: 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. Precautions: it is very important to maintain introducer patency with a saline flush to prevent occlusion of the introducer, which may interfere with delivery device advancement. Care should be taken to ensure the connection between the introducer sheath hub and the filter storage tube is tight; however, the use of excessive force which can cause slippage of the threads and/or breakage of the hub should be avoided. 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 Key5262911
MDR Text Key32792136
Report Number2020394-2015-01961
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2016
Device Catalogue NumberDL900J
Device LOT NumberGFXH2811
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 Received12/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/07/2013
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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