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 EZF21TA

Device Problems Nonstandard Device (1420); Data Back-Up Problem (2902); Detachment of Device or Device Component (2907)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Field corrective action (fca-146) has been initiated for the ez glide cannula separation issue.Aortic perfusion cannula is intended for perfusion of the ascending aorta during short-term cardiopulmonary bypass procedures.In this case, it was reported that the connector/side port section of the ez glide aortic cannula suddenly became disconnected.The patient was off bypass but was still transfusing through the cannula.Blood loss was estimated at 1-2 liters.No blood products were given, and the patient left the or in stable condition.Per the instructions for use (ifu), "securely tie-band the connector to cannula junction prior to initiating bypass to protect against tubing slippage." 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.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 the connector/side port came off the ez glide cannula.The surgeon had come off bypass, but was still transfusing through the cannula when the connector came off.The nurse held her finger on the cannula to try to stop the blood loss until the surgeon was able to clamp it off.The surgeon thinks the patient lost 1-2 liters of blood.No blood was given to the patient before leaving the or and the patient was stable at that point.No other information was provided.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.

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: 9300257
• MDR Text Key: 167144692
• Report Number: 3008500478-2019-00168
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: EZF21TA
• Device Catalogue Number: EZF21TA
• Device Lot Number: 230894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention