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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 Problem Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided for 3 out of 6 malfunctions, therefore a lot history reviews were performed. The devices were not returned for evaluation; however, medical records were provided and reviewed for all the 6 reported malfunctions. All the six reported malfunctions were confirmed for the alleged filter perforation. A definite root cause could not be determined based upon available information. The devices were labeled for single use. (corporate lot number: unknown).
 
Event Description
A review of the reported information indicates that model dl900j vena cava filter allegedly perforated. The information was received from various source. All the six reported malfunctions were involved with patients with no reported consequences. Four male patients ages were ranged from 61 to 75 years old and two female patient ages were ranged from 68 to 82 years old. Weight of two patients were ranged from 213 to 215 pounds; however,remaining patients weight were 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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key12221577
MDR Text Key263353121
Report Number2020394-2021-80673
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported6
Summary Report (Y/N)Y
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFAX2513,GFXI2542,GFZD4318
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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