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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
Model Number DL900F
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Injury (2348); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2021).
 
Event Description
It was reported through the litigation process, that the filter migrated to heart.The patient underwent a lengthy and complex heart surgery for the removal of filter.The current status of the patient is unknown.
 
Event Description
It was reported through the litigation process, that the filter migrated to heart.The patient underwent a lengthy and complex heart surgery for the removal of filter.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: 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.Investigation summary:the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for alleged filter migration as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: (expiry date: 06/2021).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.
 
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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 Key11371072
MDR Text Key233244329
Report Number2020394-2021-80190
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040801
UDI-Public(01)00801741040801
Combination Product (y/n)N
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberGFCS2585
Was Device Available for Evaluation? No
Date Manufacturer Received03/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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