MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CLEARSIGHT; CLEARSIGHT FINGER CUFF

Model Number	CSCS
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	04/18/2025
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 device history record has not yet been completed.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 small clearsight cuff was providing inaccurate values.The clearsight cuff had a damped waveform and was reading 60s over 30s with mean arterial pressures of 40 and the noninvasive blood pressure on the same side was reading 110 over 80s with map greater than 65.The clinician reported that he had removed the clearsight cuff to adjust it because there seemed to be a gap between it and the finger it was on.The patient received medications to increase the blood pressure based on the clearsight cuff readings.The clinical sales representative rep stopped monitoring removed the small clearsight cuff and remeasured the patient.The sizer indicated the patient was a medium cuff instead of a small.When the correct size cuff was placed on the patient the blood pressure values increased to 100 over 60s.There was no patient injury.The device is available for evaluation.
Additional Manufacturer Narrative
One small clearsight finger cuff was returned for evaluation.Report of inaccurate pressure reading issue was not confirmed.Finger cuff passed eeprom verification with expired status and patient information, indicating that the device had been used.Finger cuff was reset for pressure test.Finger cuff zeroed and sensed pressure on hemosphere monitor without any error message.Electrical testing showed that all elements such as shield, led, and photodiode of returned unit were ok.No visible damage was noticed from the returned finger cuff.Finger cuff sensor passed both pre and post-decontamination leak test.Per the instructions for use, improper placement or alignment of the finger cuff can lead to inaccurate monitoring.The reported malfunction was unable to be confirmed during product evaluation.However, manufacturing controls to avoid potential causes related to inaccurate values include: malfunction as follows: 100% visual inspection by mfg, 100% electrical test, and qa sampling inspection.

• Brand Name: CLEARSIGHT
• Common Device Name: CLEARSIGHT FINGER CUFF
• 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 ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22003598
• Report Number: 2015691-2025-03740
• Device Sequence Number: 9042987
• Product Code: DXN
• UDI-Device Identifier: 00690103193343
• UDI-Public: (01)00690103193343(17)260911(11)240911(10)65997457
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190130
• 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): 06/26/2025

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: 09/11/2026
• Device Model Number: CSCS
• Device Lot Number: 65997457
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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