MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CLEARSIGHT FINGER CUFF; CATHETER, FLOW DIRECTED

Model Number CSCU

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

The date of the event is unknown; however, according to the literature article, the study analysis was approved on february 9, 2022.Thus, this day was used as the date of event.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.

Event Description

The following information was obtained through an article published on journal of cardiothoracic and vascular anesthesia 2023 by martha wolfskeil, md , et al.: continuous noninvasive blood pressure measurement with clearsight compared to standard intermittent blood pressure measurement in patients with peripheral arterial disease are potential differences influenced by phenylephrine or dobutamine?.In this study, in patients with pad, cnibp-cs showed an underestimation of blood pressure compared to inibp in phenylephrine- and dobutamine-treated patients.The authors found larger biases and wider loa than most previous studies, suggesting less agreement in their study population.Whether these findings were caused solely by pad or potentially other confounding factors are involved remains to be established.This study had several limitations that should be acknowledged when interpreting the results.The authors do not have a straightforward explanation for the larger bias between both measurement methods in their study.However, the previous reports were in patients without vascular compromise, whereas the current observations were obtained in patients with pad.The applicability of cnibp-cs in patients with pad remains a subject of debate.In previous research, pad was often an exclusion criterion for comparison studies.However, several studies have included patients with known or presumed pad.An important difference from the authors study was that these studies compared cnibp-cs to invasive arterial blood pressure measurement.Systolic and diastolic pressures are then estimated using algorithms unique to each manufacturer and should not be considered as accurate as map.

Manufacturer Narrative

Updated: b5 (event description), h6 (investigation findings, investigation conclusions).As per article review, 34 patients were involved the study.The devices involved in this complaint were not received for evaluation.No images or videos were provided for investigation.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.As such, based on available information, a definite root cause is unable to be determined at this time.

• Brand Name: CLEARSIGHT FINGER CUFF
• Type of Device: CATHETER, FLOW DIRECTED
• 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; itabo carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18510645
• MDR Text Key: 333378317
• Report Number: 2015691-2024-00398
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSCU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1