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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES SWAN-GANZ CCOMBO V; CATHETER, FLOW DIRECTED Back to Search Results
Lot Number 65020842
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Right heart catheter french swan clotted off.
 
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Brand Name
SWAN-GANZ CCOMBO V
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
EDWARDS LIFESCIENCES
MDR Report Key17788902
MDR Text Key324063813
Report NumberMW5145995
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number65020842
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age38 YR
Patient SexMale
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