MAUDE Adverse Event Report: EDWARDS LIFESCIENCES OPTISITE ARTERIAL PERFUSION CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	OPTI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the report received from germany an opti18 cannula was found to have the wire outside from the cannula.As reported it was noticed, when the cannula was about to be inserted into the artery.There was no injury for the patient.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: device evaluation anticipated but not yet begun.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.
Additional Manufacturer Narrative
Customer complaint of "wire outside from the cannula" was confirmed.As received, 3 mm section of wire from the wire reinforcement of the cannula was found to be exposed and protruding from the cannula body at 2.5cm from distal tip.Wire appeared to match the length of the groove.No other visual damage or other abnormalities were found to the device.Lab findings were aligned to the customer photos.
Additional Manufacturer Narrative
Added information to section e1 (reporter name) and h6 (type of investigation) corrected section h6 (component code): 3036 (cannula) replaces 4755 (part/component/sub-assembly term not applicable) updated section h6 (investigation findings) and h6 (investigations conclusions) h11: additional manufacturer narrative: a device history record (dhr) review was performed, and no relevant non-conformances were identified.Additionally, sterilization records did not show any nonconformances, deviations, or deficiency reports.The device was returned to edwards lifesciences for further investigation, and images of the affected device were provided.Per product evaluation, customer complaint of "wire outside from the cannula" was confirmed.As received, 3 mm section of wire from the wire reinforcement of the cannula was found to be exposed and protruding from the cannula body at 2.5cm from distal tip.Wire appeared to match the length of the groove.No other visual damage or other abnormalities were found to the device.Images provided by the customer were aligned with the product evaluation findings.Per supplier communications, there are multiple inspections during the manufacturing process to check for exposed wires including 100% inspection of each cannula to ensure no exposed wires are present on cannula body.The complaint of wire outside the cannula was confirmed through evaluation of the returned device.Based on the information available, a definitive root cause cannot be conclusively determined; however, it is likely related to supplier manufacturing.Investigation is still ongoing to determine the cause.

• Brand Name: OPTISITE ARTERIAL PERFUSION CANNULAE
• 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; one edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 8015656209
• MDR Report Key: 20766834
• Report Number: 2015691-2024-08886
• Device Sequence Number: 8393498
• Product Code: DWF
• UDI-Device Identifier: 00690103180565
• UDI-Public: (01)00690103180565(17)270517(11)240517(10)BSLC6421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233895
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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: OPTI
• Device Lot Number: BSLC6421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 12/02/2024; 01/28/2025
• Initial Report FDA Received Date: 11/23/2024
• Supplement Report FDA Received Date: 12/26/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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