MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ

Lot Number 60055165

Device Problems Inflation Problem (1310); Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2016

Event Type  malfunction  

Event Description

The catheter was advanced to the right atrium.Ra pressure was taken.The balloon would not appropriately inflate and it was withdrawn.It was seen that it was a structural defect with a tear resulting in rapid balloon deflation.Reason for use: right heart catheterization.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: SWAN GANZ
• Type of Device: SWAN GANZ
• Manufacturer (Section D): EDWARDS LIFESCIENCES
• MDR Report Key: 5575999
• MDR Text Key: 42766314
• Report Number: MW5061676
• 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: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 60055165
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 65