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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC SWAN-GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC

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EDWARDS LIFESCIENCES, LLC SWAN-GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 141F7
Device Problem Occlusion Within Device (1423)
Patient Problem Thrombosis (2100)
Event Date 01/08/2016
Event Type  malfunction  
Event Description
Five swan-ganz catheters clotted within the last week.This is unusual (per md).
 
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Brand Name
SWAN-GANZ
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
EDWARDS LIFESCIENCES, LLC
one edwards way
irvine, CA 92614
MDR Report Key5366243
MDR Text Key35944736
Report Number5366243
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Model Number141F7
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/11/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/11/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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