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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL FILTER VENA CAVA FILTER Back to Search Results
Model Number 2120F
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was not provided, a lot history review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. However, medical record was received for evaluation. Therefore, the investigation is confirmed for the reported perforation and detachment. Based on the available information, the definitive root cause for this event is unknown. The device is labeled for single use.

 
Event Description

A review of the reported information indicates that model 2120f vena cava filter allegedly experienced perforation and detachment. The information was received from a single source. This malfunction involved one patient with no patient consequences. A (b)(6) years old male patient weighs (b)(6) kgs.

 
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Brand NameSIMON NITINOL 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 Key12175906
MDR Text Key261793402
Report Number2020394-2021-80568
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
Type of Report Initial
Report Date 07/15/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number2120F
Device Catalogue Number2120F
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 Received06/30/2021
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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