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Adverse Event Report

EDWARDS LIFESCIENCES FOGARTY ARTERIAL EMBOLECTOMY CATHETER   back to search results
Model Number 120602F
Event Date 12/21/2002
Event Type  Other   Patient Outcome  Required Intervention;
Event Description

While embolectomizing left femoral artery, coil at tip of embolectomy catheter interior dislodged from catheter and stuck in the side of the vessel. The doctor removed coil tip of catheter by opening site over catheter and "parching" vessel. No permanent pt injury reported.

 
Manufacturer Narrative

H6. Method, results: no device returned for evaluation.

 
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Brand NameFOGARTY ARTERIAL EMBOLECTOMY CATHETER
Baseline Brand NameFOGARTY ARTERIAL EMBOLECTOMY CATHETER
Baseline Generic NameARTERIAL EMBOLECTOMY CATHETER
Baseline Catalogue NumberNA
Baseline Model Number120602F
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Manufacturer (Section F)
EDWARDS LIFESCIENCES
1.4 km state road 402 north
anasco PR 00610
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1.4 km state road 402 north
anasco PR 00610
Manufacturer Contact
allison mezzanatto
one edwards way
irvine , CA 92614
(949) 250 -2562
Device Event Key434471
MDR Report Key445498
Event Key415789
Report Number6000002-2003-00068
Device Sequence Number1
Product CodeDXE
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 01/28/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2003
Is This An Adverse Event Report? No
Device Operator Invalid Data
Device MODEL Number120602F
Device LOT Number512FC151
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received01/28/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2002
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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