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

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.

• Type of Device: BARD IVC FILTER "RECOVERY" FILTER SYSTEM
• Manufacturer (Section F): BARD
• Manufacturer (Section D): BARD
• Device Event Key: 1639755
• MDR Report Key: 1595331
• Event Key: 1518517
• Report Number: 1595331
• Device Sequence Number: 1
• Product Code: DTK
• 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 Received: 02/02/2010
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device LOT Number: GF0E0997
• OTHER Device ID Number: RF-048F
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2009
• Device Age: 5 yr
• Event Location: Hospital
• Date Report TO Manufacturer: 07/03/2009
• 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