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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
Catalog Number DL900J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Death  
Manufacturer Narrative
Manufacturing review: a device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were not provided. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based on 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.
 
Event Description
It was reported through the litigation process that some time post vena cava filter deployment the patient expired. There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death. The cause of the patient¿s death was not provided. No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
 
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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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10113772
MDR Text Key193582388
Report Number2020394-2020-03604
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,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDL900J
Device Lot NumberGFBT3783
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
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: 06/03/2020 Patient Sequence Number: 1
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