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

Model Number	EZF21A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by our edwards lifesciences japanese affiliate, blood leaked from an ezf21a aortic cannula after initiation of cardiopulmonary bypass (cpb).The leakage occurred form the connection between the cannula body and the connector.The customer addressed the leakage with a sterile tie-band and continued to use the cannula without replacing it.Amount of the blood loss was not provided.Other than addressing the leakage with tie-band, there was no significant delay in the procedure, and there was no patient adverse event reported.The patient status was not provided.Per the reported information, the device was used for an aortic valve replacement.The device was prepared and connected to the tubing of cpb as per the ifu without any problems.De-airing was performed as usual and there was no problem observed.The device was stored horizontally on the shelf at the hospital prior to use.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: device evaluation anticipated, but the suspect device has not yet been evaluated.The reported event is pending further investigation.A supplemental report will be submitted in a timely manner once the investigation has been completed or new information becomes available.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 h3 (device evaluated by manufacturer).Updated section h2.H11: additional manufacturer narrative: per preliminary evaluation of returned device one ezf21a cannula with tubing was received.What appeared to be blood was visible at the junction between barb connector and tubing.Per product evaluation, 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.A cable tie was observed at the connector to cannula junction.A leak test was performed with cable tie and tubing removed and leakage was observed between the connector to cannula junction.No other visual damage, contamination, or other abnormalities were found.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: 20298890
• Report Number: 2015691-2024-07349
• Device Sequence Number: 18090839
• Product Code: DWF
• UDI-Device Identifier: 00690103175080
• UDI-Public: (01)00690103175080(17)270312(11)240312(10)418391
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: EZF21A
• Device Lot Number: 418391
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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