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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFE SCIENCES, LLC SWAN-GANZ CCO; CATHETER, FLOW DIRECTED
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EDWARDS LIFE SCIENCES, LLC SWAN-GANZ CCO; CATHETER, FLOW DIRECTED Back to Search Results
Catalog Number 139HF75P
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A male patient was in preparation of a coronary artery bypass surgery of three vessels and a swan ganz pulmonary artery catheter was implemented.The patient was placed in the trendelenberg position, then was prepped and draped in normal sterile fashion using a bundling technique.A modified seldinger technique was used to insert the guide wire.A vein was found with one pass using finder needle.Later, a swan ganz pulmonary artery catheter was floated into place using a pulmonary artery pressure tracing with one pass.The first balloon was noted to have a possible hole inside, and was traded out for a second device.The procedure was completed without any apparent problems or further complications.A portable chest x-ray will be obtained at the end of the case for line placement and to rule out pneumothorax.
 
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Brand Name
SWAN-GANZ CCO
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
EDWARDS LIFE SCIENCES, LLC
one edwards way
irvine CA 92614
MDR Report Key3811918
MDR Text Key4404125
Report Number3811918
Device Sequence Number1
Product Code DYG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 03/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number139HF75P
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/21/2014
Event Location Hospital
Date Report to Manufacturer05/15/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
Patient Weight77
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