MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, OXIMETER, FIBER-OPTIC

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Event Description

Swan was placed during right heart cath, however, repeated attempts to obtain swan numbers was unsuccessful in the coronary care unit (ccu).The catheter was left in place due to ability to obtain central venous pressures.There were no concerns and no harm to patient.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7424837
• MDR Text Key: 105274818
• Report Number: 7424837
• 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: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR