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

Model Number D97130F5

Device Problems Inflation Problem (1310); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2019

Event Type  malfunction  

Event Description

Defective swan ganz balloon.It did not inflate during pre case check.It was not used on patient.

• 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: 8531242
• MDR Text Key: 142481254
• Report Number: 8531242
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2019,03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• Device Lot Number: 61491767
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2019
• Date Report to Manufacturer: 04/19/2019
• Type of Device Usage: N
• Patient Sequence Number: 1