MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC SWAN-GANZ ADVANCED TECHNOLOGY PULMONARY ARTERY CATHETER; CATHETER, FLOW DIRECTED

Device Problem Leak/Splash (1354)

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

Manager called to bedside to assist staff member with troubleshooting the swan catheter that was leaking clear fluid at the hub.Pa-c also at bedside attempting to re-float catheter as the waveform is in wedge.Unable to float to obtain appropriate waveforms.Advised to pull the catheter to prevent any patient harm or injury, pa-c in agreement.Rn discontinue catheter without difficulty no abnormalities noted.Catheter was saved and sent back to manufacturer.No gaps in care or patient harm noted.

• Brand Name: SWAN-GANZ ADVANCED TECHNOLOGY PULMONARY ARTERY CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC; irvine CA 92614
• MDR Report Key: 16683621
• MDR Text Key: 312820184
• Report Number: MW5116327
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White