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

Model Number	EZC24TA
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss.The potential for serious injury before or during use is not remote.The device was returned and product evaluation is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported that the vented connector of a ezc24ta ez glide aortic cannula separated from the cannula.There were no patient injuries.Per rep this was a cabg procedure and the event occurred towards the end of the procedure.No exchange of cannula was required.No abnormality of the device or packaging was noted prior to use.Per the perfusionist the it came loose at the red-cap.It has to deal with the bonded vent connector site.The perfusionist feels the issue lies within the small vent connector barb and recommends a three barb connector.
Additional Manufacturer Narrative
A crack, approximately 0.7 long, was observed on the cannula between 2 from the distal tip and part of the wire reinforced section.No other visual damage, contamination, or other abnormalities were found to the cannula.Vent plug was not returned with device.
Additional Manufacturer Narrative
Customer complaint of the tip of a ezc24ta ez glide aortic cannula was cracked was confirmed.A crack, approximately 0.70 long, was observed on the cannula between 2 from the distal tip and part of the wire reinforced section.No other visual damage, contamination, or other abnormalities were found to the cannula.Based on the information available, the reported cannula separation was confirmed, however, the most likely cause of the reported separation is excessive force applied by the user.An edwards defect has not been confirmed.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15000396
• Report Number: 2015691-2022-06739
• Device Sequence Number: 11232885
• Product Code: DWF
• UDI-Device Identifier: 00690103714418
• UDI-Public: (01)00690103714418(17)241024(11)211025(10)328572
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EZC24TA
• Device Catalogue Number: EZC24TA
• Device Lot Number: 328572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 09/23/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/12/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown