MAUDE Adverse Event Report: EDWARDS LIFESCIENCES QUICKDRAW VENOUS CANNULAE

Model Number QD22

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Vascular perforations may occur with the use of several of our devices.A perforation is typically the result of excessive force combined with challenging anatomy and not a malfunction of the device.If there is a confirmed malfunction associated with this event, it should be captured along with any adverse event that resulted.If no known malfunction was associated with the event, capture the adverse event.In this case, there was perforation of the pulmonary artery by the venous cannula.The device was not returned for evaluation as it was discarded.Based on the available information the root cause of the event was likely due to patient and procedural factors.The device history record (dhr) was not able to be reviewed as the device lot number was not provided.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

Edwards received information that during placement of the venous cannula of an unknown size there was perforation of the pulmonary artery.No complications to the patient.Patient is well in the icu and recovering.No allegation of malfunction against the venous cannula.Event was attributed to user error.The venous cannula was discarded post procedure.

Event Description

Edwards received information that during placement of the venous cannula of an unknown size there was perforation of the pulmonary artery.The rep was not at the case and the lot number was not available.No complications to the patient.Patient is well in the icu and recovering.No allegation of malfunction against the venous cannula.Event was attributed to user error.The venous cannula was discarded post procedure.As reported the case was booked as a minimally invasive mitral repair, and the resultant procedure was a full sternotomy with mitral valve repair.Apulmonary vent catheter catheter were placed by anesthesia without problems.The surgeon believes that when he was passing up the venous cannula catheter, he may have pushed the pulmonary vent catheter forward causing the tear in the pulmonary artery.The pulmonary vent catheter was placed in the right ij and the venous cannula was placed via the right femoral vein up into the superior vena cava.

Manufacturer Narrative

Corrected data: event.

Manufacturer Narrative

An engineering evaluation was performed and a manufacturing, supplier, design, ifu, and labeling defect were not confirmed.The trend was reviewed and found to be in control.The root cause was adverse event attributed to user error.No further actions are required.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

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

• Brand Name: QUICKDRAW VENOUS CANNULAE
• Type of Device: VENOUS CANNULAE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8550307
• MDR Text Key: 143219276
• Report Number: 3008500478-2019-00127
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/02/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: QD22
• Device Catalogue Number: QD22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/19/2019; 05/31/2019; 07/23/2020
• Supplement Dates FDA Received: 05/20/2019; 05/31/2019; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention