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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 Failure to Advance (2524); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
No device, no medical records, or 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 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 deployment of a vena cava filter, the filter allegedly would not advance through the sheath and two of the filter legs were allegedly crossed. It was further reported that the filter was exchanged over the guidewire for another and the procedure was successfully completed. There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the device history records were 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: the device was returned with the product packaging and label. The caudal anchor was returned bent. No bowing or skiving in the storage tube was noted during evaluation. The pusher catheter was kinked approximately 29. 1cm from the proximal end of the handle. The kink is likely the result of the manner in which the device was packaged for return. No kinks were reported by the user. The dilator and sheath were not returned. Functional/performance evaluation: the filter was returned separate from the delivery system; therefore, no functional testing was performed. Dimensional evaluation: all measurements of the filter met the required specifications. Medical records review: medical records were not provided for review. Image/photo review: medical images were not provided for review. Conclusion: the device was returned. The investigation was inconclusive due to the filter being outside the delivery system upon return. Based upon the available information, the definitive root cause for this event was unknown. It was 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. 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 handle at anytime during this procedure. Directions for use: implantation: inspect the packaging to ensure that it has not been opened or damaged. Flush the introducer sheath intermittently by hand to maintain introducer sheath patency. Maintaining patency helps prevent clot from interfering with filter deployment. Flush the delivery device with saline through the tuohy-borst adapter. Attach the free end of the filter storage tube directly to the introducer sheath already in the vein. The introducer sheath and filter delivery system should be held in a straight line to minimize friction. Loosen the proximal end of the tuohy-borst adapter and advance the filter by moving the pusher forward through the introducer sheath. Do not twist or retract the pusher at anytime during the procedure. 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 deployment of a vena cava filter, the filter allegedly would not advance through the sheath and two of the filter legs were allegedly crossed. It was further reported that the filter was exchanged over the guidewire for another and the procedure was successfully completed. There was no reported patient injury.
 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6156571
MDR Text Key61896028
Report Number2020394-2016-01145
Device Sequence Number1
Product Code DTK
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue NumberDL900J
Device Lot NumberGFAR3121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2016
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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