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

Device Problem Insufficient Information (3190)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

In icu temporary pacemaker intermittent capture, returned to ep lab, removed and replaced with new catheter.

• 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: 15437260
• MDR Text Key: 300064838
• Report Number: 15437260
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/07/2022,09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2022
• Date Report to Manufacturer: 09/16/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27375 DA
• Patient Sex: Female