MAUDE Adverse Event Report: EDWARDS LIFESCIENCES QUICKDRAW VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number QD22

Device Problems Material Separation (1562); Device Slipped (1584)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 10/16/2018

Event Type  Death  

Manufacturer Narrative

Udi #(b)(4).These cannula are used to divert large volumes of blood from the heart to the cardiopulmonary bypass machine during cardiac surgery procedures.If not detected prior to use, the bypass machine may alarm for decreased flow.A partial or complete separation will require exchange of the cannula, temporary interruption of bypass, and in a worst case scenario retrieval of the device fragment.Depending on the location of the fracture/separation, it may also result in significant blood loss.In this case, the root cause of this event cannot be conclusively determined with the available information.The subject device was not returned for evaluation.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.

Event Description

It was reported that the tubing of a quickdraw venous cannula separated from the connector intraoperatively.The patient was on ecmo and a second device was needed to finish the case.The patient was on vv ecmo and then coded.When trying to transition to va ecmo, the cannula was clamped to be off support.At that point, the connector slipped from the plastic of the cannula.This event then caused the ecmo circuit to quickly deprime requiring replacement.Approximately 15-20 minutes passed until the patient could be placed on support.The patient subsequently expired.

Manufacturer Narrative

Additional manufacturer narrative: the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: QUICKDRAW VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8052078
• MDR Text Key: 126592442
• Report Number: 3008500478-2018-00091
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K981995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

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 Expiration Date: 05/09/2020
• Device Model Number: QD22
• Device Catalogue Number: QD22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 12/03/2018; 07/23/2020
• Supplement Dates FDA Received: 12/10/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention