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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER Back to Search Results
Model Number DL900F
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2018
Event Type  Injury  
Manufacturer Narrative
No medical records were provided to the manufacturer. X-ray is pending. The lot number for the device was provided. The device history records is currently under review. The investigation is currently under way. ( expiration date: 06/2021). The information provided by bard 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 bard.
 
Event Description
It was reported that during a vena cava (ivc) filter deployment procedure, the filter legs allegedly failed to expand. It was further reported that the filter allegedly migrated toward right ventricular. Reportedly, the health care provider was not able to retrieve the filter which result in transferring the patient to the hospital for possible intervention. Patient status is unknown.
 
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Brand NameDENALI VENA CAVA FILTER
Type of DeviceVENA 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 NY 12804
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7906123
MDR Text Key121605040
Report Number2020394-2018-01786
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberGFCS2585
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/25/2018 Patient Sequence Number: 1
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