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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 DL950J
Device Problems Difficult to Insert (1316); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2017
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified in section has not been cleared in the us, but is similar to the denali jugular filter products that are cleared in the us. The 510k number and pro code for the denali jugular filter products are identified. Accordingly, this event has been determined to be mdr reportable. 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. The device was returned for evaluation and photos were provided for review. The returned filter had two crossed filter legs. The photos provided also show the same crossed filter limbs. Therefore, the investigation is confirmed for failure to expand due to the crossed filter limbs. The investigation is inconclusive however for the alleged insertion difficulties as the sheath was not returned for evaluation. Based upon the available information, the definitive root cause is unknown. 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: 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. (b)(4).
 
Event Description
It was reported that during a vena cava filter deployment procedure, it was difficult to insert the delivery sheath. Upon deployment, contrast injection demonstrated that filter legs were crossed; however the filter remained implanted. Sixteen days post filter deployment, the filter was captured and retrieved successfully. There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the (b)(4) filter products that are cleared in the us. The 510 k number and pro code for the (b)(4) filter products are identified. Accordingly, this event has been determined to be mdr reportable. No hospital/medical records or 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 device has been returned to the manufacturer for evaluation. 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 procedure, it was difficult to insert the delivery sheath. Upon deployment, contrast injection demonstrated that filter legs were crossed; however the filter remained implanted. Sixteen days post filter deployment, the filter was captured and retrieved successfully. 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 Key6896001
MDR Text Key250003398
Report Number2020394-2017-01225
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeJA
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 11/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberDL950J
Device Lot NumberGFBS0813
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2017
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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