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Adverse Event Report

EDWARDS LIFESCIENCES FOGARTY EMBOLECTOMY CATHETER   back to search results
Model Number 120602F
Device Problem Dislodged
Event Date 12/21/2002
Patient Outcome  Other;
Event Description

Left femoral exploration artery - while embolectomizing, embolectomy catheter interior dislodged from catheter and stuck in the side of patient's leg. Physician removed catheter by opening site over catheter and "parching" vessel before closing.

 
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Brand NameFOGARTY
Type of DeviceEMBOLECTOMY CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
EDWARDS LIFESCIENCES
irvine CA 92614 5686
Manufacturer (Section D)
EDWARDS LIFESCIENCES
irvine CA 92614 5686
Device Event Key428262
MDR Report Key439328
Event Key415789
Report Number439328
Device Sequence Number1
Product CodeDXE
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/09/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/01/2004
Device MODEL Number120602F
Device Catalogue Number120602F
Device LOT Number512FC151
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/09/2003
Distributor Facility Aware Date12/21/2002
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer01/09/2003
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on December 31, 2008

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