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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FILTER VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. DENALI FILTER VENA CAVA FILTER Back to Search Results
Catalog Number DL900J
Device Problems Difficult to Flush (1251); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/16/2014
Event Type  Malfunction  
Manufacturer Narrative

A further review of this event was performed and identified a change in the mdr reportability pursuant to 21 cfr part 803. 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 inspection: returned for evaluation is the denali jugular filter delivery system. The returned device delivery system and storage tube/y-body appeared to be clean. The filter was returned inside of the storage tube. The pusher catheter exhibited one kink approximately 29. 4cm from the proximal end of the handle. It is unknown how or when the kink occurred as it was not reported by the user. The manner in which the device was packaged for return may have contributed to the kink. The storage tube and y-body were received separated from the pusher catheter. Functional/performance evaluation: the storage tube was flushed without issue. The filter was manually removed from the distal end of the storage tube. All 6 arms and 6 legs were present and intact. The storage tube showed no signs of skiving. No anomalies were identified. All measurements met the required specifications. Medical records review_ image/photo review: medical records were not provided. No images or photos were provided. Conclusion: based upon the returned sample condition, the complaint investigation is confirmed for the gripper dislocating from the filter snare hook. The complaint investigation is confirmed for advancement issues as the filter was returned inside the storage tube. The investigation is inconclusive for difficult to flush as the conditions of use could not be recreated. Labeling review: the denali vena cava filter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. 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 procedure, difficulty flushing the deployment system and disengagement of the filter hook interface was experienced. The filter could not be advanced out of the storage tube. The filter deployment system was exchanged for a new filter deployment system, the filter was deployed successfully. There is no reported patient injury.

 
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Brand NameDENALI FILTER
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 Key5033780
MDR Text Key24425851
Report Number2020394-2015-01495
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
Reporter Occupation
Type of Report Initial
Report Date 09/18/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2017
Device Catalogue NumberDL900J
Device LOT NumberGFYD2726
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/09/2014
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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