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

Model Number 151F7

Device Problems Material Rupture (1546); Unexpected Therapeutic Results (1631)

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

Event Date 05/30/2023

Event Type  Injury  

Event Description

Balloon on edwards thermodilution catheter (swan-ganz) item number 151f7 spontaneously perforated while clinical staff attempted to obtain wedge pressure.Item was used according to manufacturer's instructions for use and had been functioning appropriately in the hours prior to this event.Patient may have received air intravascularly during attempts to inflate balloon.Precautionary measures taken after event to manage risk of venous air embolism.

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.
• MDR Report Key: 17109016
• MDR Text Key: 317125802
• Report Number: MW5118323
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 151F7
• Device Catalogue Number: 151F7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White