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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2020
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review will not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

 
Event Description

It was reported through the litigation process that the filter migrated and detached. Approximately fourteen years nine month post filter deployment a radiological imaging revealed that the filter struts perforated the inferior vena cava wall. The current status of the patient is unknown.

 
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Brand NameRECOVERY FILTER 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 Key10693172
MDR Text Key211856897
Report Number2020394-2020-20155
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF048F
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
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: 10/16/2020 Patient Sequence Number: 1
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