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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 Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
Event Type  malfunction  
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 been returned to the manufacturer for evaluation.However, a video was 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.Expiration date: 05/2023.
 
Event Description
It was reported that during a filter placement procedure for the treatment of deep vein thrombosis in lower extremities through jugular vein, the filter allegedly failed to deploy.There was no reported patient injury.
 
Manufacturer Narrative
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 electronic video was reviewed.The radiography video shows, the filter is completely out of its sheath and the filter was not able to be deployed.Based on the image review, the investigation is confirmed for failure to expand and positioning problem.One jugular denali delivery system was returned for evaluation.Components received include one filter, one filter storage tube and one touhy-borst adapter attached onto a pusher catheter, one dilator, and one introducer sheath.The filter was received within the filter storage tube.The filter was noted to be partially deployed with multiple legs intertwined.Under microscopic observation of the dilator tip it was noted that, it appeared to be blunt and partially frayed.No functional testing was performed due to condition of the device.Based on these findings the investigation is confirmed for deformation due to compressive stress as the dilator tip appeared to be blunt and partially frayed.Therefore, based on the image review and returned sample analysis the investigation is confirmed for failure to expand, positioning problem and deformation due to compressive stress.A definitive root cause for the alleged positioning problem, failure to expand and identified deformation due to compressive stress could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the catalog number identified in section d4 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 in d2 and g4.H10: d4(expiry date: 05/2023),g3,h6(method) h11: section a through f ¿ the information provide by bd represents all 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.
 
Event Description
It was reported that during a filter placement procedure for the treatment of deep vein thrombosis in lower extremities through jugular vein, the filter allegedly failed to deploy.There was no reported patient injury.
 
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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 Key12210455
MDR Text Key262893716
Report Number2020394-2021-01373
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 07/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDL950J
Device Lot NumberGFES2896
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Date Manufacturer Received07/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
Patient Weight60
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