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

Model Number 777F8

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

Attempted to remove pa line through cordis it would not come out easily.Decision made to pull cordis along with pa line.When catheter and cordis examined the metal filament on pa line was snagged on cordis and was difficult to pull through the cordis.

• Brand Name: SWAN GANZ CCOMBOV
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 17729532
• MDR Text Key: 323195164
• Report Number: 17729532
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/02/2023

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
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: NOT AVAILABLE
• 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: 08/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White