MAUDE Adverse Event Report: EDWARDS LIFESCIENCES THIN-FLEX SINGLE STAGE VENOUS DRAINAGE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	TF028L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11 additional manufacturer narrative- the device is not available for evaluation.No harm or specific malfunction was reported but this event is being reported out of an abundance of caution.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
It was reported that a tf028l venous cannula was exchanged with a larger tf030l cannula due to poor venous drainage following the initiation of cardiopulmonary bypass.There were no patient adverse events reported.The patient outcome was reported as under treatment.Per the reported information, the device was used during mitral valve replacement and concomitant coronary artery bypass grafting.This 28f size was chosen based on the patient body build and anatomical consideration without any confusion regarding the relationship between side and corresponding flow rate.No visual abnormalities were observed in the packaging prior to opening and in the device itself after opening.During use, there was no kinking of the cannula, and no external force was applied to the cannula.The surgeon affirmed that there was no malfunction of the device and the device did not cause or contribute to the event.He commented that the small size of the cannula was the cause of the inadequate venous drainage.The device was not returned for evaluation as it was discarded at the hospital.
Additional Manufacturer Narrative
Manufacturer narrative: g3/ g6/ h2 and h6 updated.H3 reselected.Additional information per engineering investigation - the reported complaint was unable to be confirmed as no product was returned.Risk documentation and labelling considered appropriate at this time.Dhr review was conducted - good documentation practices were followed properly, and no nonconformities or deviations were found to be associated with the work order.Retained samples were obtained to evaluate form and o.D dimensions, no abnormalities were detected.Mitigations include a validated oven cycle and dimensional inspection is performed at 100% to connector area & spring section.The event description did include "the surgeon affirmed that there was no malfunction of the device and the device did not cause or contribute to the event.He commented that the small size of the cannula was the cause of the inadequate venous drainage." per the instructions for use, "proper surgical procedures and techniques are the responsibility of the medical professional.Described procedures are provided for informational purposes only.Each physician must determine the appropriate use of this device for each patient based on medical training, experience, the type of procedure employed, and the benefits and risks associated with device use." the most likely cause of the event is either the wrong size was selected by the medical professional or another factor during the operation led to the event.No evidence of an edwards/ supplier nonconformance was found.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: THIN-FLEX SINGLE STAGE VENOUS DRAINAGE CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8018424930
• MDR Report Key: 23007665
• Report Number: 2015691-2025-07410
• Device Sequence Number: 13223497
• Product Code: DWF
• UDI-Device Identifier: 00690103041002
• UDI-Public: (01)00690103041002(17)270904(11)240904(10)440445
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: TF028L
• Device Lot Number: 440445
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown