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

Model Number 777F8

Device Problem Defective Device (2588)

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

Event Date 02/23/2023

Event Type  malfunction  

Event Description

Early: 2023; cardiovascular operating room (cvor): prep for surgical procedure.Swan: ganz showed error code:(check thermal filaments position) cco/cci would not function.Attempted trouble shooting, not successful.Another one tried with a different lot # and the same thing happened.The 3rd one used without a problem.No known harm to patient, delay in procedure.Manufacturer response for catheter, flow directed, swan-ganz ccombo v (per site reporter).Will obtain.

• Brand Name: SWAN-GANZ CCOMBO V
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16536583
• MDR Text Key: 311216627
• Report Number: 16536583
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)241128(11)221129(10)64762706
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64762706
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1