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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the devices were not provided, a lot history review was not performed. The samples were not returned to the manufacturer for evaluation; however, medical records were received and reviewed. For one malfunction, the investigation of the reported malfunctions was confirmed for material deformation and retrieval difficulties and inconclusive for filter tilt. For the other malfunction, the investigation is confirmed for tilt, material deformation and retrieval difficulties. Based upon the available information, the definitive root cause for these malfunctions were unknown. The devices are labeled for single use.

 
Event Description

This report summarizes two malfunctions. A review of the reported information indicated that the model rf048f vena cava filter allegedly reported filter difficult to remove, tilt and material deformation. This information was received from various sources. The two malfunctions involved patients with no known impact to the patient. The first patient was (b)(6) old male and the second patient was (b)(6) old male; however, the weights of both the patients were unknown.

 
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Brand NameRECOVERY FILTER
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 Key10308133
MDR Text Key199874771
Report Number2020394-2020-04887
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 NumberRF048F
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

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