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

Model Number 831F75

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/11/2016

Event Type  malfunction  

Event Description

Serous fluid traveled up the catheter to the thermistor hub, rendering it inoperative.

• Brand Name: SWAN GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES TECHNOLOGY SARL; one edwards way; irvine, CA 92614
• MDR Report Key: 5697971
• MDR Text Key: 46559907
• Report Number: 5697971
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 831F75
• Device Catalogue Number: 831F75
• Device Lot Number: 60313653
• Other Device ID Number: 173199003A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1