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

Model Number	TF024O90
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11 additional manufacturer narrative- the device is not available for evaluation as it was discarded.No harm or specific malfunction was reported.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
As reported by our edwards lifesciences japanese affiliate, a tf024o90 venous cannula was exchanged with a larger tf028o90 cannula due to poor venous drainage after the initiation of cardiopulmonary bypass.The operation was completed with no patient adverse events reported.The patient's outcome was not provided.No further information was provided by the customer.
Additional Manufacturer Narrative
Updated section b4.Updated sections g3, g6.Updated sections h2, h6 - type of investigation; investigation findings; investigation conclusions.H11: additional manufacturer narrative: the reported complaint was unable to be confirmed as no product was returned.Per supplier dhr review, no non-conformances for the subject production lot were found.No deviations to current process were found.All inspections were completed by trained personnel.Individual dhrs for all involved subassemblies (sub-assembly included bodies and tips) were reviewed with no observed non-conformances or deviations.Current inspections include 100% inspection for visual deformities that could affect device performance when in use.Due to limited information received, the complaint was unable to be confirmed.Per the instructions for use (ifu), '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 operational factors, including selection of the incorrect size by the medical professional.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: 23479999
• Report Number: 2015691-2025-09079
• Device Sequence Number: 10499068
• Product Code: DWF
• UDI-Device Identifier: 00690103040937
• UDI-Public: (01)00690103040937(17)270808(11)240808(10)436724
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: TF024O90
• Device Lot Number: 436724
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown