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

Model Number	774F75
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device of this complaint was received for evaluation; however, the device investigation is ongoing.When the product investigation is completed, a supplemental report will be sent with the investigation results.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.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, when using this swan-ganz catheter, the error message's fault: co check thermal filament position and fault: co catheter verification, use bolus mode were displayed on the monitor.The monitor was checked and no issues were found.Despite the alarms, cardiac output could be monitored using the ico through bolus mode.As per product evaluation findings, proximal thermal filament cover had a tear at the junction between the cover and the bond.Torn edges of the cover did not appear to match up.There is no allegation of patient injury.Patient demographics were not provided.
Additional Manufacturer Narrative
The device was received for evaluation.The report of error message was confirmed.When running cco on hemosphere monitor, "fault: co-check thermal filament position" error massage was shown and stopped cco monitoring.The thermistor was found to read 37.0 degrees c when submerged into a 37.0 degrees c water bath.Thermistor and thermal filament circuit were continuous; there were no open or intermittent conditions.No visible inconsistencies were observed on eeprom data.Resistance value of thermal filament circuit was measured to be within specification.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Proximal thermal filament cover had a tear at the junction between the cover and the bond.Torn edges of the cover did not appear to match up.Based on the available information there is no evidence that supports or confirms the failure mode of the issue of the damaged thermal filament cover is associated to a manufacturing or design defect.There are controls to verify this condition in the manufacturing process where thermal filament visual inspection is performed where any thermal filament issues are verified.Additionally, the initial issue of error message was found to be related to device manufacturing process.

• Brand Name: SWAN-GANZ CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 22068362
• Report Number: 2015691-2025-04043
• Device Sequence Number: 9374625
• Product Code: DYG
• UDI-Device Identifier: 00690103146998
• UDI-Public: (01)00690103146998(17)260424(11)240424(10)65643948
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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
• Device Expiration Date: 04/24/2026
• Device Model Number: 774F75
• Device Lot Number: 65643948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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