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

Model Number	EZC24A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11 manufacturer narrative per initial product evaluation, the report of cannula leakage was confirmed.Device was returned with visible blood residue at the connector to cannula junction and the barb connector to tubing junction.Wax-like material was visible at the connector to cannula junction.A white cable tie was observed at the same location as the wax-like material.As part of visual evaluation, bonding between cannula and connector with solvent was indicated.A leak test was performed with cable tie removed and leakage was observed between the connector to cannula junction.No other visual damage, contamination, or other abnormalities were found.The reported event is pending additional investigation and historical record review.A supplemental report will be submitted accordingly once the full investigation 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.
Event or Problem Description
It was reported that an ezc24a (lot 425099) started to ooze at the proximal end, just below the cannulation connection.This occurred as soon as they went on bypass at the beginning of the procedure.The surgeon used bone wax and ties to try and stop the oozing but had to replace the ezc24a cannula with another of the same model from a different lot.Then the surgeon was able to finish the case successfully.The amount of blood loss due to leakage is unknown.No patient injury reported.No abnormalities were noted and there was no additional processing of the device prior to use.There was no prolonged compression of the cannula.It was used during an ascending arch cabg case.Patient information not provided.Line pressure unknown.
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).Updated section h2.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 LLC; 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: 20212513
• Report Number: 2015691-2024-07097
• Device Sequence Number: 8151749
• Product Code: DWF
• UDI-Device Identifier: 00690103714401
• UDI-Public: (01)00690103714401(17)270507(11)240507(10)425099
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: EZC24A
• Device Lot Number: 425099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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