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

Model Number (01)0069010300405

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

Swan-ganz catheter td (thermodilution) port damaged, unable to connect to numerous wires.Prongs on the co (cardiac output) connection was missing.

• Brand Name: SWAN-GANZ TD CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17755836
• MDR Text Key: 323685195
• Report Number: MW5145679
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: (01)0069010300405
• Device Catalogue Number: 131F7
• Device Lot Number: (17)250302(11)23030
• 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 Number: 1
• Patient Age: 55 YR
• Patient Sex: Male