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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
Model Number DL900J
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/22/2021
Event Type  Injury  
Manufacturer Narrative
A lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record (dhr) review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. There were no device deficiencies identified within the medical records. Therefore, the investigation is inconclusive for the alleged filter limb detachment and filter migration as no objective evidence has been provided to confirm any alleged deficiency with the filter. The definitive root cause could not be determined based upon available information. Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (expiry date: 10/2016).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient reason for filter placement was not provided. At some time post filter deployment, it was alleged that filter detached and migrated to heart. The device and the detached struts were removed by unknown removal procedure. The current status of the patient is unknown.
 
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Brand NameDENALI JUGULAR SYSTEM
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 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11320179
MDR Text Key231585647
Report Number2020394-2021-00230
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 consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFXG3750
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/12/2021 Patient Sequence Number: 1
Treatment
AVELOX, AUGMENTIN AND BACTRIM; LEVOTHYROXINE SODIUM, SIMVASTATIN
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