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

Model Number	SWAN GANZ UNKNOWN
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Edwards lifesciences was unable to perform due diligence efforts to retrieve the suspect device for analysis as there was no customer contact information provided in the voluntary incident report.No product was returned for evaluation; therefore, a definitive root cause could not be determined, and corrective or preventive action is not indicated at this time.
Event or Problem Description
Edwards lifesciences was notified via a direct voluntary incident report submission to the fda that a patient experienced complete heart block after post implant of a transcatheter bioprosthetic valve.There was intermittent failure of the temporary pacing wire leading to short periods of asystole.The temporary pacing wire was repositioned.Subsequently a permanent pacemaker was implanted with no adverse patient effects reported.There was no patient injury.The voluntary incident report did not include customer contact information patient information or product information related to the reported event.

• Brand Name: SWAN GANZ UNKNOWN
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 21404335
• Report Number: 2015691-2025-01109
• Device Sequence Number: 15780910
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: 00690103150438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K822723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Device Catalogue Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown