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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned for evaluation.Medical records were provided and reviewed.Therefore, the investigation is confirmed for tilt, difficult to remove, perforation and material deformation.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.
 
Event Description
A review of the reported information indicated that model rf310f vena cava filter experienced tilt, difficult to remove, perforation and material deformation.The information was received from a one source.This malfunction involved one patient with no patient consequences.The (b)(6) year old male patient was (b)(6).
 
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Brand Name
G2 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 Key12199972
MDR Text Key262645688
Report Number2020394-2021-80643
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 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberRF310F
Device Lot NumberGFRE0624
Date Manufacturer Received06/30/2021
Type of Device Usage N
Patient Sequence Number1
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