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

Model Number	774F75
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient, after a left ventricular assist device (lvad) placement, this swan ganz catheter provided incorrect mixed venous oxygen saturation (sv02) value.The hemosphere indicated an svo2 of 84% while the gas showed 48%.After this calibration, it was a good measurement until there was suddenly another increase to 63%, while the gas was at 43%.No error message was displayed.There was no allegation of patient injury.Patient demographics were requested and unable to be obtained.
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section d9, h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report of "incorrect mixed venous oxygen saturation (sv02) value" was unable to be confirmed.Catheter passed in-vitro calibration in received condition.Balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.No visible damage was observed from returned syringe.As per further testing, the catheter passed attenuation test.Catheter body had a kink at 95cm from tip.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.Concerning the report of incorrect values, no root cause could be determined since the failure mode could not be confirmed during the device evaluation.As part of the manufacturing process the units go through an optical inspection process to measure the svo2 and final packaging inspection.Additionally, with regards to the issue of kink encountered during product evaluation, based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.

• 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 ; 9492503939
• MDR Report Key: 22793391
• Report Number: 2015691-2025-06604
• Device Sequence Number: 18221289
• Product Code: DYG
• UDI-Device Identifier: 00690103146998
• UDI-Public: (01)00690103146998(17)260910(11)240910(10)65955338
• 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): 10/23/2025

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 Expiration Date: 09/10/2026
• Device Model Number: 774F75
• Device Lot Number: 65955338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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