MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT ELITE SENSORS, LARGE; FORESIGHT SENSORS

Model Number	FSESL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The lot number was not provided thus a device history record will not be reviewed.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
It was reported during use that the fsesl foresight sensors readings were within normal range for 3 hours but then slowly drifted to 55 and 59 while assessing cerebral oximetry.Intervention included the doctor trying to improve the oximetry reading by adjusting etco2 blood pressure and giving blood but the readings remained low.The doctor replaced the suspect foresight sensors with new foresight sensors and the cerebral oximetry was reading 65 bilaterally.No known patient harm or injury was noted.
Additional Manufacturer Narrative
One foresight elite large sensor was returned for evaluation.The sensor was returned without the attached liner.No visible damage was observed from the sensor.No visible damage or contamination was noticed from the connector area.Report of issue with foresight sensors readings was not able to be confirmed.The sensor monitored sto2 on the hemosphere monitor without any error message.Both sto2 value and signal quality index were also stable.As the lot number not reported, device history record could not be located and reviewed.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The reported condition could not be confirmed; therefore, no product or process malfunction was identified.A root cause could not be established.

• Brand Name: FORESIGHT ELITE SENSORS, LARGE
• Common Device Name: FORESIGHT SENSORS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20787923
• Report Number: 2015691-2024-08957
• Device Sequence Number: 7883245
• Product Code: MUD
• UDI-Device Identifier: 00690103208146
• UDI-Public: 00690103208146
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: FSESL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/19/2025
• 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