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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 Problem Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the five reported malfunctions were not provided, therefore lot history reviews were not performed. For another two malfunction the lot number was provided and lot history review was performed. The devices were not returned, however, medical records were provided for six out of seven malfunctions. For four of the malfunctions that provided medical records perforation of the ivc were confirmed. For two malfunction that provided medical records the investigation is identified for perforation of the ivc. For the remaining 1 malfunction, medical records were not provided for review, therefore the investigations is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon the available information, the definitive root cause is unknown. The devices are labeled for single use.

 
Event Description

This report summarizes seven malfunctions. A review of the reported information indicated that model rf048f vena cava filter was allegedly experienced perforation. This information was received from various sources. All seven malfunctions were involved with no patient consequences. Three of the patients were male and three were female. Three male patient's ages ranged from 33-63 years and three female patient age ranged from 50-75. One patient age and weight not provided. All other patients weight not provided.

 
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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 Key10314950
MDR Text Key200207547
Report Number2020394-2020-05004
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 07/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberRF048F
Device LOT NumberGFOG1384, GFOJ4345
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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