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

Model Number	CSCM
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	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a failure with one clearsight cuff.There were inaccurate readings during use with the cuff.The non-invasive blood pressure cuff was being used along with the clearsight cuff.The reading from the clearsight cuff was 20 to 30mmhg lower than the mean arterial pressure reading from the non-invasive blood pressure cuff.The clinicians placed the clearsight cuff in a different location on the patient, but there was still the 20 - 30mmhg difference between the two technologies.The patient's hands were warm and the capillary refill was brisk on both sides.There was no inappropriate patient treatment administered.There was no patient harm or injury.
Additional Manufacturer Narrative
The product has arrived for evaluation.The product evaluation results are pending.Once the results become available a supplemental report will be submitted.The device history record review has not been completed.Once completed the results will be submitted in a supplemental report.Another product code is dsb.Another 510k number is k160552.
Additional Manufacturer Narrative
The clearsight finger cuff was returned for product evaluation.The product evaluation found that the reported issue could not be confirmed.There was no defect identified.The finger cuff zeroed successfully and sensed pressure successfully on a hemosphere monitor without any error messages displayed.Electrical testing showed that all elements such as shield, led, and photodiode of the finger cuff passed testing.The finger cuff sensor passed both pre and post-decontamination leak test.There was no visible damage that was found on the finger cuff.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.However, there are manufacturing controls to avoid potential causes related to inaccurate values which include, visual inspection and electrical testing of 100 percent of devices in addition to quality sampling inspections.It is not known if any 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 a monthly review.

• Brand Name: CLEARSIGHT
• Common Device Name: CLEARSIGHT FINGER CUFF MEDIUM
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; parque industrial de itabo; dominican republic; carr sanchez km 18.5
• Manufacturer Contact: katheryn cespedes ; one edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 21096580
• Report Number: 2015691-2025-00119
• Device Sequence Number: 8665000
• Product Code: DXN
• UDI-Device Identifier: 00690103193350
• UDI-Public: (01)00690103193350(17)260824(11)240824(10)65970332
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140312
• 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): 03/20/2025

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: 08/24/2026
• Device Model Number: CSCM
• Device Lot Number: 65970332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2024
• 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