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 EZC24TA

Device Problems Break (1069); Disconnection (1171); Nonstandard Device (1420); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Field corrective action (fca-146) has been initiated for the ez glide cannula separation issue.Since the device is in the vasculature, component separation may result in embolization of that portion of the device.This may require retrieval which can often be done percutaneously.Attempts for retrieval are performed to prevent complications such as infection or thrombosis, which may occur in the short or long term.Potential for injury is not remote.For devices that are used in the extra-vascular space, a separation may result in retention of the tip in the thoracic or abdominal cavity.Although less serious than an intravascular separation, there is a long term risk of infection.Attempts has been made to obtain the product.The subject device was not returned for evaluation; therefore, the reported event cannot be confirmed.The root cause of this event remains indeterminable.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to monitor all events.If new information becomes available, a supplemental report will be submitted accordingly.

Event Description

It was reported that an ez glide aortic cannula tip came off after cannulation.When the cannula was connected to the bypass circuit, the tip/upper portion of the cannula did not immediately separated.The section was clamped with forceps/hemostat.There were no cracks or chips in the cannula that caused the disconnection.The patient was reported to be okay.

Manufacturer Narrative

Customer report of separated tip from ez glide cannula was confirmed.As received, the tip of the cannula was separated from main cannula body.Indications of what appeared to be bonding material were found on both the detached tip end and the cannula body.Cannula appeared bent on the cannula body at the wire-reinforced section.No other visual damage, contamination, or other abnormalities were found to the device.

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: 9830923
• MDR Text Key: 207362627
• Report Number: 3008500478-2020-00192
• 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: company representative,distri
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2020

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 Expiration Date: 09/11/2021
• Device Model Number: EZC24TA
• Device Catalogue Number: EZC24TA
• Device Lot Number: 217048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 03/23/2020; 05/22/2020; 07/23/2020
• Supplement Dates FDA Received: 04/09/2020; 05/22/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1