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

Model Number	TF010O90
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Edwards received a report where the surgeon noticed the neck/ tip of a 10fr plastic right-angle cannula (tf010o90) was longer than usual.It was not used, and a new tf010o90 was opened from a different lot.It is available for return and images were provided.There was no patient involvement, and it was reported there was no impact on the procedure.A response has been requested.
Additional Manufacturer Narrative
H11/h3: initial evaluation summary: customer report of neck/ tip of a 10fr plastic right-angle cannula (tf010o90) was longer was confirmed.Returned sample was observed to be longer compared to a reference sample returned by the user.Reference length measurements of the canula body and tip were taken.The length measurement of the cannula bonding engagement was measured at approximately 0.16".The length measurement of the cannula tip area c was measured at approximately 0.65".The length measurement of the cannula tip area d was measured at approximately 0.55".No other visual damage, contamination, or other abnormalities were found to the device.No visual damage, contamination, or other abnormalities were found to the reference device.Photos provided by the customer were consistent with lab findings.H11: additional manufacturer narrative: the reported event was confirmed through preliminary evaluation of the device.The reported event is pending final evaluation analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.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.
Additional Manufacturer Narrative
H11 manufacturer narrative: g3/ h2/ h3 selected for follow up.H6 codes for investigation type, findings, and conclusions updated.The complaint is not considered to be confirmed as the device meets current acceptance criteria per supplier evaluation.Per the dhr and mitigation review, good documentation practices were followed, and no nonconformances/ deviations were associated with the production work order.Retained samples were found to have no abnormal condition.Mitigations are in place to inspect for bend and length.The returned samples were evaluated by nordson and found to meet the current acceptance criteria.A manufacturing nonconformance was not confirmed.Based on available information, the complaint of the device being longer than usual and the suspicion of the device being out of tolerance is not confirmed.Image evaluation and product evaluation did confirm the device was longer than the reference unit with reference measurements.However, per the supplier evaluation both units were found to be acceptable.The variance in tip length is tied to the manufacturing process, but in this case, both returned units are considered as acceptable, and the current controls are deemed adequate.Using the qualified test methods in manufacturing, no defect was found.There is no evidence to suggest an edwards/ supplier manufacturing defect.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: EDWARDS THIN-FLEX SINGLE STAGE VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8018424930
• MDR Report Key: 21774592
• Report Number: 2015691-2025-02595
• Device Sequence Number: 8220492
• Product Code: DWF
• UDI-Device Identifier: 00690103040661
• UDI-Public: (01)00690103040661(17)270905(11)240905(10)440431
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: TF010O90
• Device Lot Number: 440431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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