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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK CELECT VENA CAVA FILTER IVC FILTER

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COOK CELECT VENA CAVA FILTER IVC FILTER Back to Search Results
Model Number IGTCFS-S5-FEM-CELECT
Event Date 04/12/2010
Event Type  Death  
Event Description

Retroperitoneal hematoma and hemorrhage due to multiple perforations of inferior vena cava by prongs of caval filter. Filter placed (b)(6) 2009 "cook celect vena cava filter". Perforation took place between (b)(6) 2010 and (b)(6) 2010 following elective surgery to reanastomose fallopian tubes. Dates of use: (b)(6) 2009 - (b)(6) 2010. Diagnosis or reason for use: history of pulmonary embolism.

 
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Brand NameCOOK CELECT VENA CAVA FILTER
Type of DeviceIVC FILTER
MDR Report Key1737917
Report NumberMW5016480
Device Sequence Number1
Product CodeDTK
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 06/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIGTCFS-S5-FEM-CELECT
Device LOT NumberE2471868
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 06/22/2010 Patient Sequence Number: 1
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