MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT ELITE SENSOR LARGE; FORESIGHT SENSOR

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	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and not available for return.The device history record review is pending and has not been completed.Once the results are available a supplemental report will be submitted with the findings.H3 other text : discarded.
Event or Problem Description
It was reported that there was a malfunction with the foresight sensor, large.It stopped sensing during an open heart procedure.It occurred when the clinicians started cooling on cardiopulmonary bypass.They could not obtain a consistent reading.The numbers would drop, even though the hemodynamics were unchanged.The numbers expected and the numbers displayed are unknown.When they pushed on the sensor on the patient forehead, the numbers returned to baseline.They exchanged the suspect sensor for a different sensor.There was no inappropriate patient treatment.The patient demographics are unknown.There was no patient injury.
Additional Manufacturer Narrative
The device history record review was completed.All manufacturing inspections passed with no non-conformances.As the device was discarded, without its return it is not possible to determine if some damage or defect existed on the device that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.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 the monthly review.The other sensor that was involved in this event was reported under submission number 2015691-2024-00463.

• Brand Name: FORESIGHT ELITE SENSOR LARGE
• Common Device Name: FORESIGHT SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn richards ; one edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18530681
• Report Number: 2015691-2024-00457
• Device Sequence Number: 20469267
• Product Code: MUD
• UDI-Device Identifier: 00690103208146
• UDI-Public: (01)00690103208146(17)250321(11)230321(10)43202313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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: 03/21/2025
• Device Model Number: FSESL
• Device Lot Number: 43202313
• Was Device Available for Evaluation?: No
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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