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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 Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the three malfunctions were not provided and hence a lot history review was not performed. For the three malfunctions the sample was not returned to the manufacturer for inspection/evaluation. For one malfunction medical records were provided and reviewed and the investigation is confirmed for filter migration, filter tilt and retrieval difficulties. For the other two malfunctions medical records were provided and the investigation identified filter migration, filter tilt and retrieval difficulties. A definite root cause for the reported event could not be determined. The device was labeled for single use.

 
Event Description

This report summarizes three malfunctions. A review of the reported information indicated that model rf310f vena cava filter allegedly experienced difficult to remove, tilt and migration. These reports were received from various sources. All three events involved a patient with no reported patient consequences. Of the three reported patient, three patients ranged from 30 ¿ 68 years of age, one patient weight was 108 kgs and two were male and one was female; however, other patients weight was not provided.

 
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Brand NameG2 FILTER SYSTEM - FEMORAL
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 Key10309561
MDR Text Key199915244
Report Number2020394-2020-04932
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 07/22/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberRF310F
Device LOT NumberUNKNOWN
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 Initial

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