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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A review of the reported information indicated that model ec500f vena cava filter allegedly experienced tilt, migration, material deformation and difficult to remove.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) male patient weighs (b)(6).
 
Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; however, medical records and images were provided and reviewed.The investigation is confirmed for filter tilt, retrieval difficulties, filter migration and material deformation.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
 
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Brand Name
ECLIPSE FILTER SYSTEM - FEMORAL
Type of Device
VENA 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 Key13287947
MDR Text Key284019197
Report Number2020394-2022-90037
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberEC500F
Device Lot NumberGFVF4242
Initial Date Manufacturer Received 12/31/2021
Initial Date FDA Received01/19/2022
Type of Device Usage A
Patient Sequence Number1
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