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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 DL900F
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported that during a filter retrieval procedure, the surgeon allegedly found material in the filter.It was further reported that the filter was removed using a snare.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; however, a manufacturing review was performed to verify manufacturing records as the user reported device contamination with chemical or other material.The lot met all release criteria.Investigation summary: a surgical gauze containing six unknown material fragments was returned for evaluation.However, no denali filter kit components were returned.Fragments were noted to be bloody, under microscopic examination material was noted to be shaved plastic.However, the investigation is inconclusive for device contamination with chemical or other material as the device was not returned and there is no proper evidence to confirm.Two electronic photos were reviewed.Photo 1 shows a denali device lot and catalog number written in the biohazard bag, it is matching the reported information in complaint.The second photo shows a surgical gauge containing around seven unknown material fragments.Fragments where noted to be bloody.Based on the photo review the reported device contamination with chemical or other material cannot be confirmed.A definitive root cause for the alleged device contamination with chemical or other material could not be determined based upon the provided information.Labeling review: the current instructions for use states: optional procedure for filter removal.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.Precaution: the retrieval of the denali® vena cava filter should only be performed using minimum 9f i.D./11f i.D.Dual retrieval sheaths.Misuse of these devices or improper retrieval technique may result in intimal injury or caval narrowing.H10: d4 (expiry date: 02/2024), g3, h6 (method).H11: d1, d4, h6 (result and 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.
 
Event Description
It was reported that during a filter retrieval procedure, the surgeon allegedly found material in the filter.It was further reported that the filter was removed using a snare.There was no reported patient injury.
 
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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
MDR Report Key12083511
MDR Text Key258913376
Report Number2020394-2021-01258
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 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDL900F
Device Lot NumberGFFN3077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Initial Date Manufacturer Received 06/02/2021
Initial Date FDA Received06/29/2021
Supplement Dates Manufacturer Received08/23/2021
Supplement Dates FDA Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
Patient Weight80
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