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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 DL950J
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Activation Failure (3270)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed. The device has not been returned to the manufacturer for evaluation. However, an image is provided for review. The investigation of the reported event is currently underway. The catalog number identified has not been cleared in the us but is similar to the denali filter system products that are cleared in the us. The pro code and 510 k number for the denali filter system products are identified. (expiry date: 06/2023).
 
Event Description
It was reported that during vena cava filter deployment, the leg of the filter was allegedly twisted and the filter allegedly failed to expand. The filter was migrated into right atrium. It was further reported that the filter was removed by using snare, and another filter was placed successfully. There was no reported patient injury.
 
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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 Key10852429
MDR Text Key216626589
Report Number2020394-2020-20440
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDL950J
Device Lot NumberGFET2677
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Yes
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: 11/17/2020 Patient Sequence Number: 1
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