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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD, INC.SIMON NITINOL IVC FILTER

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BARD, INC. SIMON NITINOL IVC FILTER   Back to Search Results
Lot Number GFWG2467
Event Date 01/14/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

In the deployment of an infrarenal simon nitinol filter, the legs of the filter did not deploy. This required placement of a retrieval sheath and to reposition the filter and properly open the filter legs. There was add'l difficulty disengaging the filter snare after successful repositioning, and groin access was obtained to assist in disengaging the retrieval snare from the ivc filter.

 
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Brand NameSIMON NITINOL IVC FILTER
Type of DeviceSIMON NITINOL IVC FILTER
Manufacturer (Section F)
BARD, INC.
salt lake city UT
Manufacturer (Section D)
BARD, INC.
salt lake city UT
Device Event Key2954522
MDR Report Key2928508
Event Key2955996
Report NumberMW5028681
Device Sequence Number1
Product CodeDTK
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/16/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device LOT NumberGFWG2467
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

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