MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS LIFESCIENCES EZ GLIDE 21 FR CANNULA; CATHETER, CANNULA TUBING VASCULAR CARDIOPULMONARY BYPASS

Model Number EZC21TA

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 08/05/2019

Event Type  Injury  

Event Description

Device: edwards lifesciences ez glide 21 french aortic cannula, ref # ezc21ta malfunction: seal on manufacture created connection came undone during cardiac surgery.During a coronary artery bypass operation while the pt was on cardiopulmonary bypass (cpb) with the 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 pt.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 approx 5l/min.Failure to clamp the pump out in seconds will lead to exsanguinating the pt into the drapes.To fix the problem, we had to turn the cpb machine 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.Insert a new cannula.Remove the air from the aortic cannula and turn the cpb machine back on.During this time, the pt is not supported by cpb, is in circulatory arrest, and since we were moments away from finishing the case, normothermic.We were to re-establish cpb and finish the case but the event represented serious threat to the pt's life as well complications, particularly stroke from air embolism.Fda safety report id# (b)(4).

• Brand Name: EDWARDS LIFESCIENCES EZ GLIDE 21 FR CANNULA
• Type of Device: CATHETER, CANNULA TUBING VASCULAR CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 8901327
• MDR Text Key: 154876368
• Report Number: MW5089074
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2019

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
• Device Operator: Health Professional
• Device Model Number: EZC21TA
• Device Catalogue Number: EZC21TA
• Device Lot Number: 224662
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 70 YR
• Patient Weight: 75