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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number DL950F
Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2023
Event Type  malfunction  
Event Description
It was reported that during a vena cava filter placement procedure via the left femoral vein, the filter allegedly had resistance in the progression of the filter pusher.It was further reported that the procedure was performed via the right jugular vein without any difficulty.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the denali filter products that are cleared in the us.The pro code and 510k number for the denali filter products is identified in d2 and g4.H10: 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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2025) 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.
 
Event Description
It was reported that during a vena cava filter placement procedure via the left femoral vein, the filter allegedly had resistance in the progression of the filter pusher.It was further reported that the procedure was performed via the right jugular vein without any difficulty.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the denali filter products that are cleared in the us.The pro code and 510k number for the denali filter products is 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 femoral jugular system kit was returned for evaluation.During the visual evaluation, the received filter was inside storage tube along with the detached portion of the pusher wire.Upon functional test, filter and detached portion of pusher wire was deployed by using pusher catheter with some resistance.The distal tip of the storage tube was deformed.Based on the findings the investigation is confirmed for the reported failure to advance issue as the filter was in the storage tube.The investigation is also confirmed for the identified detached issue as the pusher wire was detached in to two portion and the investigation is confirmed for the identified material deformation issue as device distal tip of storage tube was note to be deformed.A definitive root cause for the reported failure to advance and identified detached and material deformation issues 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: d4 (expiry date: 02/2025), g3, h6 (method).H11: h6 (result, conclusion).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 FEMORAL SYSTEM
Type of Device
VENA 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 12804
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key17285076
MDR Text Key318770723
Report Number2020394-2023-00502
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040825
UDI-Public(01)00801741040825
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDL950F
Device Lot NumberGFGP0348
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2023
Date Manufacturer Received07/25/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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