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

Catalog Number 834F75

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

Pt undergoing right heart catheterization.All ports flushed prior to start of procedure.During procedure, md having difficulty with waveforms.Md took caps of to flush catheter again, he observed yellow plastic sticking out of ra infusion port.

• Brand Name: SWAN GANZ VIP
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.
• MDR Report Key: 10867821
• MDR Text Key: 217371642
• Report Number: MW5097973
• Device Sequence Number: 1
• Product Code: DYG
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Catalogue Number: 834F75
• Device Lot Number: 63239425
• Was Device Available for Evaluation?: Yes
• 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: 82 YR
• Patient Weight: 78