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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FILTER VENA CAVA FILTER Back to Search Results
Model Number DL900J
Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

As the lot number was provided for two devices, a device history review was performed, the lot number was not provided for one malfunction and hence a device history review could not be performed. The samples were not returned to the manufacturer for inspection/evaluation however, medical records were provided for review. A review of the medical records confirmed filter perforation and migration for all three malfunctions. Based upon the available information, the definitive root cause for this event is unknown. The devices are labeled for single use.

 
Event Description

This report summarizes three malfunctions. A review of the reported information indicated that model dl900j vena cava filter allegedly experienced perforation and migration. This information was received from various sources. Of the three malfunctions, three patients were involved with no patient consequences or impact. The three patients ranged from 54 through 92, one was male and two were female. The weight was not provided for any of the patients.

 
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Brand NameDENALI 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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10312814
MDR Text Key200020293
Report Number2020394-2020-04981
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberDL900J
Device Catalogue NumberDL900J
Device LOT NumberGFYA3092; GFYL3318; UNKNOWN
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 Received06/30/2020
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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