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Adverse Event Report

CORDIS CORDIS GF DIAGNOSTIC CATH   back to search results
Lot Number L0500404
Patient Outcome  Required Intervention;
Event Description

Two cordis catheters failed (leaking preventing standard removal procedure). No extra-ordinary stress, 2 different pt's - both from new lot and treated on same location 1 foot from hub.

 
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Brand NameCORDIS
Type of DeviceGF DIAGNOSTIC CATH
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
CORDIS
*
Device Event Key307860
MDR Report Key318333
Event Key299303
Report NumberMW1021222
Device Sequence Number1
Product CodeDQO
Report Source Voluntary
Report Date 02/16/2001
2 DeviceS WERE Involved in the Event:1 2 
1 Patient Was Involved in the Event
Date FDA Received02/16/2001
Is This An Adverse Event Report? No
Device Operator Health Professional
Device LOT NumberL0500404
Was Device Available For Evaluation? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

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