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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - JUGULAR VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number EC500J
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Patient-Device Incompatibility (2682)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/23/2011
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 04/2013).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before orthopedic procedure. At some time post filter deployment, it was alleged that the filter migrated to heart and struts perforated into organs. The device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The current status of the patient is unknown.
 
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Brand NameECLIPSE FILTER SYSTEM - JUGULAR
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 Key11647202
MDR Text Key244833856
Report Number2020394-2021-80289
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093659
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 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500J
Device Lot NumberGFUC2244
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2021
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: 04/12/2021 Patient Sequence Number: 1
Treatment
LISINOPRIL, JANUMET AND HUMULIN; PRISTIQ, AMITRIPTYLINE, OMEPRAZOLE, MECLIZINE
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