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	Insufficient Information (4580)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: additional manufacturer narrative: device evaluation anticipated, but the suspect device is yet to be 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 of returned suspect device, as received, one ezc21a cannula with tubing.What appeared to be blood was visible at the junction between connector to cannula.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
As reported by our edwards lifesciences japanese affiliate there was blood leakage observed at the connection between the connector and the ezc21a cannula tube after the pump was initiated during use.Specific timing after the pump initiation was unknown.The leakage was about 1 drip in 5 to 10 seconds.The device was kept using.There was no impact to the overall outcome of the procedure.The surgeon did not consider the incident a significant delay in the procedure.There was no change in procedural strategy required due to the leakage.The patient status was reported as 'recovering'.The device was used for pediatric heart surgery.Per the report, no abnormalities in appearance were observed before or after use.The cannula was connected to the cpb tubing as always.Strong force was not necessary to connect them.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the subject device was evaluated.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 with 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: 20533920
• Report Number: 2015691-2024-08099
• Device Sequence Number: 6697636
• Product Code: DWF
• UDI-Device Identifier: 00690103174182
• UDI-Public: (01)00690103174182(17)270305(11)240305(10)417265
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 417265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown