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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC SWAN-GANZ CATHETER; CATHETER, FLOW DIRECTED

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EDWARDS LIFESCIENCES, LLC SWAN-GANZ CATHETER; CATHETER, FLOW DIRECTED Back to Search Results
Model Number 831F75
Device Problems Deflation Problem (1149); Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2015
Event Type  malfunction  
Event Description
An edwards vip swan ganz catheter was in the left ij cordis.After wedge was performed, the syringe did not deflate and release air.Then the syringe was pulled back on to ensure the balloon was deflated and blood return was noted in syringe.The swan ganz catheter was removed and balloon rupture was noted.
 
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Brand Name
SWAN-GANZ CATHETER
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
EDWARDS LIFESCIENCES, LLC
one edwards way
irvine, CA 92614
MDR Report Key5010560
MDR Text Key23268328
Report Number5010560
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 08/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nurse
Device Model Number831F75
Device Lot Number59757969
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/05/2015
Device Age2 DY
Event Location Hospital
Date Report to Manufacturer08/05/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/18/2015
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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