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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARDBARD IVC FILTER "RECOVERY" FILTER SYSTEM

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BARD BARD IVC FILTER "RECOVERY" FILTER SYSTEM   Back to Search Results
Lot Number GF0E0997
Device Problems Filter break(s); Device, or device fragments remain in patient
Event Date 04/04/2009
Event Type  Injury   Patient Outcome  Other,Required Intervention
Event Description

Pt had bard ivc temporary filter placed in 2004. In (b) (6) 2009, pt came in with chest pain and sob. During cardiac cath noted fragments of the ivc filter in right ventricle. Ct angio revealed fragment of ivc filter in liver. Decision made not to remove fragments. Risk was too great. Pt did have pulmonary embolism.

 
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Type of DeviceBARD IVC FILTER "RECOVERY" FILTER SYSTEM
Manufacturer (Section F)
BARD
Manufacturer (Section D)
BARD
Device Event Key1639755
MDR Report Key1595331
Event Key1518517
Report Number1595331
Device Sequence Number1
Product CodeDTK
Report Source User Facility
Source Type Unknown
Reporter Occupation Other
Type of Report Initial
Report Date 07/03/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Device LOT NumberGF0E0997
OTHER Device ID NumberRF-048F
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/01/2009
Device Age5 yr
Event Location Hospital
Date Report TO Manufacturer07/03/2009
Was Device Evaluated By Manufacturer? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

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