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	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by our edwards lifesciences japanese affiliate, blood leaked from the connector part of an ezf21a aortic cannula after initiation of cardiopulmonary bypass (cpb).The amount of blood leakage was small, so the customer determined that there was no risk to the patient and continued to use the cannula without replacing it.There was no patient adverse event reported.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: preliminary evaluation of subject device was performed; however, the final evaluation is yet to be completed.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.Per preliminary evaluation of returned device 'one ezf21a cannula with opened pouch packaging from reported model and lot number.Unknown contamination were found at the connector to cannula junction that appears to be traces of blood.' 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 h2.Per preliminary evaluation of returned device, one ezf21a cannula with opened pouch packaging from reported model and lot number was received.What appeared to be blood was visible at the junction between connector to cannula.Per product evaluation, report of cannula leakage was confirmed.Device was returned with visible blood residue at the connector to cannula junction.A leak test was performed 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: 20321825
• Report Number: 2015691-2024-07443
• Device Sequence Number: 7862757
• Product Code: DWF
• UDI-Device Identifier: 00690103175080
• UDI-Public: (01)00690103175080(17)270109(11)240110(10)411030
• 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: 411030
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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