MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ VIP; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 831F75

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2021

Event Type  malfunction  

Event Description

Swan ganz catheter was inserted.The line was placed with the use of a guidewire and ultrasound.The guidewire was removed with entire length intact and undamaged.The line was used without incident to monitor the patient during and after surgery and in icu.On the next day, the line was no longer needed, and care team was having difficulty removing the catheter.This is usually a smooth removal for this device.After several attempts and some force, the catheter was finally removed and inspected.It was found to be "abnormally bumpy" between the 30-15cm markings.There was no harm to the patient.The device was placed in a bag and labelled.Unfortunately, there was no device lot number available for this report.I will await company feedback for next steps if they want device returned.

• Brand Name: SWAN-GANZ VIP
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11982538
• MDR Text Key: 255657119
• Report Number: 11982538
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 831F75
• Device Catalogue Number: 831F75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 38