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

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Patient returned to unit from or after procedure.Registered nurse was assessing swan ganz catheter and preparing to perform thermodilution procedure to measure pa pressures.When rn flushed swan catheter, she noted fluid and blood leaking from a hole on the catheter tubing.Rn alerted provider, who advised to pull swan.Rn kept catheter tubing and placed it in a red bio-bag with patient's information on the bag.Bag given to unit cns.

• Brand Name: SWAN GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 15904416
• MDR Text Key: 304698367
• Report Number: 15904416
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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: 05/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White