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

Model Number 746F8

Device Problem Component Missing (2306)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 03/05/2020

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 9834734
• MDR Text Key: 183519024
• Report Number: 9834734
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103002881
• UDI-Public: (01)00690103002881
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 62685955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 68