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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, FLOW DIRECTED
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EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, FLOW DIRECTED Back to Search Results
Model Number D97120F5
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2021
Event Type  malfunction  
Event Description
The pacing catheter was removed from package, upon inflation of the balloon it would not inflate.The port to inflate and deflate the balloon was checked to make sure it was working properly but it still would not inflate.
 
Event Description
The pacing catheter was removed from package, upon inflation of the balloon it would not inflate.The port to inflate and deflate the balloon was checked to make sure it was working properly but it still would not inflate.
 
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Brand Name
SWAN-GANZ
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
MDR Report Key13497410
MDR Text Key285328742
Report Number13497410
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/22/2021,12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberD97120F5
Device Catalogue NumberD97120F5
Device Lot Number63633109
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2021
Event Location Hospital
Date Report to Manufacturer02/09/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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