MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	EZC21A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ezc21a of lot 423540 was noted to be leaking during a case.The leak was noted between the device connector and the main body and likely occurred after bypass was initiated.It was noticed just prior to terminating cpb when the towel covering the cannula was removed.No abnormalities were noted during preparation of the device.There was no reported difficulty in connecting the cannula to the circuit tubing and no prolonged force/compression was applied on the cannula.Patient blood volume was used to de-air the cannula and there was no difficulty in de-airing.The outcome of the procedure was reported to be normal and there is no known impact on the patient.There was no delay in the procedure and the device was not exchanged for another device.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: device evaluation anticipated, but the suspect device has not yet been evaluated.The reported event is pending final evaluation analysis.A supplemental report will be submitted in a timely manner once the evaluation has been completed.Per preliminary investigation, 'as received, one ezc21a cannula.What appeared to be blood was visible at the junction between connector to cannula.' per product evaluation, 'report of cannula leakage was unable to be confirmed during product evaluation.A leak test was performed on the as received cannula and no leakage was observed between the connector to cannula junction.No visual damage, contamination, or other abnormalities were found.Engineering task has been opened and assigned for further investigation.' 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
Updated section b4 (date of this report) and g3 (date received by manufacturer).Updated section g6 (type of report and follow-up number filled out.).Updated section h2 (follow-up type).H11: corrected data.The reported issue is related to a cannula leak that occurred at the connection between the cannula body and the connector.However, the incident involves a minor leakage at the junction between the ez glide cannula and the connector and there were no associated injuries or blood transfusions required.As a result, the severity of this non-conformance is limited.Therefore, this leakage issue will result only in procedural delay with no risk for the patient.Based on this information, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EZ GLIDE AORTIC 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 ; 8015656209
• MDR Report Key: 20446783
• Report Number: 2015691-2024-07828
• Device Sequence Number: 20899718
• Product Code: DWF
• UDI-Device Identifier: 50690103174187
• UDI-Public: (01)50690103174187(17)270422(11)240422(10)423540
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K123370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: EZC21A
• Device Lot Number: 423540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 88 KG