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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. NITINOL FILTER VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation; however medical records were provided and reviewed. Therefore, the investigation of the reported malfunction is confirmed for filter limb detachment, perforation and filter tilt. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicates that model unknown filter vena cava filter allegedly perforated, struts detached and tilted. The information was received from a single source. One patient was involved with no reported patient injury. The male patient is 71 years old. Weight of the patient was not provided.

 
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Brand NameNITINOL 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 Key10311348
MDR Text Key199979537
Report Number2020394-2020-04970
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 NumberUNKNOWN FILTER
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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