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

Model Number EZC24TA

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2022

Event Type  Injury  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 295784144
• Report Number: 2015691-2022-06739
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00690103714418
• UDI-Public: (01)00690103714418(17)241024(11)211025(10)328572
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/19/2022; 09/23/2022
• Supplement Dates FDA Received: 08/12/2022; 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening