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

Model Number	746F8
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly patient with history of severe aortic stenosis undergoing a coronary artery bypass graft x 2 with aortic valve replacement.When the edwards lifescience swan-gantz was checked prior to usage, there was no balloon on the swan-gantz device.The device was not used on the patient, no harm to patient.

• Brand Name: SWAN-GANZ COMBO
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 9834734
• Report Number: 9834734
• Device Sequence Number: 2636688
• Product Code: DYG
• UDI-Device Identifier: 00690103002881
• UDI-Public: (01)00690103002881
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/06/2020
• Report Date (Section F): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 62685955
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68
• Date Report Sent to FDA: 03/06/2020