MAUDE Adverse Event Report: EDWARDS LIFESCIENCES,L LLC. EDWADS SWAN GANZ CATHETER PULMONARY ARTERY CATHTER; CATHETER, FLOW DIRECTED

Model Number C146FZ

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2020

Event Type  malfunction  

Event Description

Swan ganz catheter balloon had a slow leak allowing air to escape into the patient¿s bloodstream.This product is latex free and the balloons are very friable.Fda safety report id # (b)(4).

• Brand Name: EDWADS SWAN GANZ CATHETER PULMONARY ARTERY CATHTER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES,L LLC.
• MDR Report Key: 9569757
• MDR Text Key: 174670496
• Report Number: MW5092132
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C146FZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 93