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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 Migration or Expulsion of Device (1395); Malposition of Device (2616); Activation Failure (3270)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image is provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the denali filter system products that are cleared in the us.The pro code and 510 k number for the denali filter system products are identified.(expiry date: 06/2023).
 
Event Description
It was reported that during vena cava filter deployment, the leg of the filter was allegedly twisted and the filter allegedly failed to expand.The filter was migrated into right atrium.It was further reported that the filter was removed by using snare, and another filter was placed successfully.There was no reported patient injury.
 
Event Description
It was reported that during vena cava filter deployment, the leg of the filter was allegedly twisted and the filter allegedly failed to expand.The filter was migrated into right atrium.It was further reported that the filter was removed by using snare, and another filter was placed successfully.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one denali filter along with a snare retrieval catheter was returned for evaluation.Filter was received attached to a snare retrieval catheter.The filter was received expanded with no entanglement present.No bowing noticed.The dimensional observations for filter long leg span, short leg span, caudal anchor leg span and arm span were within the acceptable range.Although, the sample was returned two low quality images were provided and reviewed.The first image shows an inferior vena cava filter that the filter legs are crossed and not expanded.The image appear to be from a procedure with the inferior vena cava filter located to the right of the spine.On the second image the filter is tilted toward the anatomic right.Based on the image review, the reported activation failure and identified filter tilt can be confirmed as the crossed filter legs and not expanded filter can be seen in the provided images.However, the investigation is inconclusive for reported filter migration issue as on the findings no conclusion can be made.A definitive root cause for the reported activation failure, filter migration and identified filter tilt could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 06/2023).H11:section a through f - the information provided by bd 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 bd.H3 other text : see h10.
 
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Brand Name
DENALI JUGULAR SYSTEM
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10852429
MDR Text Key216626589
Report Number2020394-2020-20440
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
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDL950J
Device Lot NumberGFET2677
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Date Manufacturer Received05/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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