MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR SWAN-GANZ CCOMBO V; CATHETER, CONTINUOUS FLUSH

Model Number	777F8
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes include dyg catheter, flow directed.A report is being submitted due to product evaluation findings of an unknown substance within the catheter balloon.Report of cco issue or blood was noted in the balloon was unable to be confirmed.No fault messages showed up on the lab hemosphere monitor when the catheter was connected.The catheter ran cco in 37.0 c water bath on hemosphere monitor for 5 minutes with no error.The thermistor was found to read 36.9 c when submerged into a 37.0 c water bath.Thermistor temperature reading accuracy is +/- 0.3 c per hemosphere manual.Thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.Resistance value of thermal filament circuit, 39.05 ohms, was in specification of 33.0 to 43.0 ohms.Both thermistor and thermal filament connectors were opened and found no visible inconsistencies.All through lumens were patent without any leakage or occlusion.The balloon inflated concentric and remained inflated for more than 5 minutes without leakage.Unknown yellow liquid was visible in the balloon.No visible damage was observed from catheter body.The device history record was not performed as no lot number was provided.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect as no defect was found.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 a part of the monthly review.
Event or Problem Description
As reported during use the swan ganz catheter was monitoring erroneous values on the cco.No error message was displayed but the waveforms were abnormal.Blood was noted in the balloon upon removal.The catheter was not used to infuse the distal port but only to monitor.It was replaced about 12 hours after insertion.There was no patient injury.The device is available for evaluation.

• Brand Name: SWAN-GANZ CCOMBO V
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 25566610
• Report Number: 2015691-2026-16179
• Device Sequence Number: 13332297
• Product Code: KRA
• UDI-Device Identifier: 00885403522348
• UDI-Public: 00885403522348
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• 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: 06/15/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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