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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 139F75
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/14/2019
Event Type  malfunction  
Event Description
Swan-ganz catheter defective. Rn unable to remove connection at hub. Entire catheter and cordis had to be removed at once. Patient remained stable. No adverse effects noted.
 
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Brand NameSWAN-GANZ
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
MDR Report Key8669768
MDR Text Key147027917
Report Number8669768
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/21/2019,05/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number139F75
Device Catalogue Number139F75
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2019
Event Location No Information
Date Report to Manufacturer06/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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