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Adverse Event Report

EDWARDS LIFESCIENCES FOGARTY ARTERIAL EMBOLECTOMY CATHETER   back to search results
Model Number 120404F
Device Problem Device breakage
Event Type  Other   Patient Outcome  Required Intervention;
Event Description

Reportedly the catheter's balloon tip broke off in the pt while trying to retrieve a broken balloon from the catheter reported on medwatch #6000002-2003-00177. Another catheter was successfully used to remove the balloon tip from the patient's graft. No permanent pt injury was reported.

 
Manufacturer Narrative

D9. Device not returned for evaluation. Company only received the empty shipping tube. H6. Method: no device returned for evaluation. Results: no device returned for evaluation.

 
Search Alerts/Recalls

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Brand NameFOGARTY ARTERIAL EMBOLECTOMY CATHETER
Type of DeviceEMBOLECTOMY CATHETER
Baseline Brand NameFOGARTY ARTERIAL EMBOLECTOMY CATHETER
Baseline Generic NameEMBOLECTOMY CATHETER
Baseline Catalogue NumberNA
Baseline Model Number120404F
Baseline Device 510(K) Number
Baseline Device PMA Number
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 Key446393
MDR Report Key457411
Event Key433286
Report Number6000002-2003-00182
Device Sequence Number1
Product CodeDXE
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 04/07/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/01/2004
Device MODEL Number120404F
Device LOT Number512HC707
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/15/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age8 mo
Event Location Hospital
Date Manufacturer Received04/07/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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