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Adverse Event Report

BARD PERIPHERAL DIV. REMOVABLE IVC FILTER RECOVERY FILTER SYSTEM   back to search results
Model Number RF-048-F
Device Problems Puncture; Implant, removal of
Event Date 09/25/2003
Patient Outcome  Hospitalization; Required Intervention
Event Description

Ivc filter inserted in 2003. Pt with progressively worsening pain. 16 days later pt went to emergency dept with severe right inguinal pain. Ct angio showed 2 struts of ivc filter poked beyond superior vena cava wall into psoas muscle & probably impinging nerve causing severe pain. Pt received nerve block 2 days later. The next day pt returned to radiology 2 days later for removal of ivc filter without complication.

 
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Brand NameREMOVABLE IVC FILTER
Type of DeviceRECOVERY FILTER SYSTEM
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD PERIPHERAL DIV.
1625 west 3rd st
tempe AZ 85281
Manufacturer (Section D)
BARD PERIPHERAL DIV.
1625 west 3rd st
tempe AZ 85281
Device Event Key476758
MDR Report Key487899
Event Key462575
Report Number487899
Device Sequence Number1
Product CodeDTK
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 09/30/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/01/2006
Device MODEL NumberRF-048-F
Device LOT Number07HN0263
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2003
Distributor Facility Aware Date09/25/2003
Event Location Hospital
Date Report TO Manufacturer09/30/2003
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

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