MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSI; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EZC21TA

Device Problems Break (1069); Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Stroke/CVA (1770); Vascular System (Circulation), Impaired (2572); No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term cardiopulmonary bypass procedures.In this case, it was reported that an ez glide aortic cannula suddenly became disconnected at the prefabricated connector site where the aortic cannula attaches to the cpb circuit.This required immediately stopping bypass and inserting a new cannula.Cpb was re-established, and the procedure was completed with no patient harm.The potential risk for significant blood loss and air embolism is high.Per the instructions for use (ifu), the user is directed to "if supplied, the white porous vent plug is designed to fit securely into the back of the lumen of aortic perfusion cannulae without a pre-attached connector.For cannulae with a pre-attached connector, the red vent cap is designed to fit securely around the connector barb.Use the appropriate porous vent plug or vent cap to ensure proper function." also, "securely tie-band the connector to cannula junction prior to initiating bypass to protect against tubing slippage." the subject is not available to be returned for evaluation as it has been sequestered by the hospital; therefore, the reported event cannot be confirmed.The root cause of this event remains indeterminable.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 Description

As reported, the ez glide aortic cannula suddenly became disconnected at the prefabricated connector site where the aortic cannula attaches to the cpb circuit.This required immediately stopping bypass and inserting a new cannula while the patient is in circulatory arrest.Cpb was re-established, and the procedure was completed with no patient harm.Additional information received indicated that the seal on the manufacture created connection came undone during cardiac surgery.During a coronary artery bypass operation while the patient was on cardiopulmonary bypass (cpb) with cross clamp applied, the connector that comes attached to the aortic cannula became undone.This connector is where the aortic cannula attaches to the cpb circuit and comes prefabricated to the aortic cannula.Essentially, what was left was an aortic cannula which no longer had its connector attached because it was now with the cpb tubing that was disconnected from the cannula and the patient.This site of connection was under the drapes so it took a few seconds to realize.These seconds are precious because the cpb is going at approximately 5l/min.Failure to clamp the pump out in seconds will lead to exsanguinating the patient into the drapes.To fix the problem, the cpb machine was turned off by clamping it out.Cut out the previous connector because once its bonded seal is broken as in this case, it can no longer simply be reattached to the old cannula.A new cannula was inserted.Removed the air from the aortic cannula and turn the cpb machine back on.During this time, the patient was not supported by cpb, was in circulatory arrest, and since the surgical team was moments away from finishing the case, normothermic.Cpb was re-establish and finish the case but the event represented serious threat to the patient¿s life as well complications, particularly stroke from air embolism.

Manufacturer Narrative

Field corrective action (fca-146) has been initiated for the ez glide cannula separation issue.

Manufacturer Narrative

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.An engineering evaluation was completed and a manufacturing defect was confirmed.Further investigation was initiated to determine the root cause of the issue and perform any necessary corrective actions.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSI
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9175022
• MDR Text Key: 164095081
• Report Number: 3008500478-2019-00160
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/19/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: EZC21TA
• Device Catalogue Number: EZC21TA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 11/13/2019; 07/23/2020
• Supplement Dates FDA Received: 11/04/2019; 11/19/2019; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR