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

Model Number	774F75
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/25/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was further informed that the device was not available for evaluation since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
As reported, during the postoperative course following 3-vessel coronary artery bypass surgery, a swan-ganz catheter was placed at approximately 1:30 am after a patient therapy-refractory shock of unclear origin.Ten minutes after measuring the pulmonary wedge pressure, the patient developed an endobronchial hemorrhage, confirmed by bronchoscopy as bleeding from the right lower lobe or segment 6 of the right lung.This led to an increasing hemodynamic instability and blood loss via both indwelling pleural drains.At around 1:50 am, the decision was made to initiate va-ecmo (veno-arterial extracorporeal membrane oxygenation), but despite ongoing therapy with pressure infusion, high-dose vasopressors and inotropes, cardiac arrest occurred at 1.55 am, and resuscitation was initiated.Va-ecmo was finally implanted at approx.2:30 am.Due to continued massive transfusion requirements, a bedside thoracotomy was performed, revealing a severe bleeding from multiple sites at the lung hilum, which could not be surgically controlled.The patient died at 03:56 am.User communicated that it was not possible to determine if the event was related or not to the device.The device was not retained for evaluation.
Additional Manufacturer Narrative
Updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).As reported, ten minutes after measuring the pulmonary wedge pressure with this swan ganz catheter placed in a patient suffering a therapy-refractory shock of unclear origin during the postoperative course following 3-vessel coronary artery bypass surgery, the patient suffered endobronchial hemorrhage.Patient got hemodynamic instable and va-ecmo (veno-arterial extracorporeal membrane oxygenation) was initiated, but despite ongoing therapy with pressure infusion, high-dose vasopressors and inotropes, cardiac arrest occurred and patient died.User communicated that it was not possible to determine if the event was related or not to the device.The device was not retained for evaluation.User report does not contain a clear allegation of relationship between our device and the patient death.Also, the device was discarded and not available for further investigation.Based on that, further investigation could not be completed and no root cause could be identified.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The ifu states: maintenance and use in situ: "catheter tip migration anticipate spontaneous catheter tip migration towards periphery of pulmonary bed.Continuously monitor distal lumen pressure to verify tip position.If wedge tracing is observed when balloon is deflated, pull catheter back.Damage may be caused by prolonged occlusion or over distension of vessel upon re-inflation of the balloon.Spontaneous catheter tip migration towards the periphery of the lung occurs during cardiopulmonary bypass.Partial catheter withdrawal (3 to 5 cm) just before bypass should be considered, as it may help reduce distal migration and prevent permanent catheter wedging post bypass.After termination of bypass, the catheter may require repositioning.Check the distal pulmonary artery tracing before inflating the balloon." and "spontaneous tip wedging: the catheter may migrate into the distal pulmonary artery and spontaneous tip wedging may occur.To avoid this complication, pulmonary artery pressure should be monitored continuously with a pressure transducer and display monitor.Forward advancement should never be forced if resistance is encountered".The ifu has been reviewed, and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of this monthly review.No corrective or preventative actions are required at this time.

• Brand Name: SWAN-GANZ CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 23725942
• Report Number: 2015691-2025-09779
• Device Sequence Number: 10691448
• Product Code: DYG
• UDI-Device Identifier: 00690103146998
• UDI-Public: (01)00690103146998(17)270709(11)250709(10)66844441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 774F75
• Device Lot Number: 66844441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Female