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

Model Number 777F8

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2023

Event Type  malfunction  

Event Description

Balloon intact at time of device setup, balloon failed during attempted placement.

• 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: 16263889
• MDR Text Key: 308367570
• Report Number: 16263889
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64483102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2023
• Date Report to Manufacturer: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Sex: Male