MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EZC21TA

Device Problems Crack (1135); Fracture (1260); Nonstandard Device (1420); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

This device is inserted into the aorta during cardiac surgery.Cracks in the material may lead to loose fragments in the vasculature which could embolize distally and cause infarction.Potential for injury is not remote.The device was not returned for evaluation as it was discarded.The device history record was not able to be reviewed as the lot number was unknown.The root cause of the event remains indeterminable.An engineering evaluation will be performed.Field corrective action ((b)(4)) has been initiated for the ez glide cannula separation issue.

Event Description

Edwards received information that an ezc21ta cannula split at the tip during use in the aorta.As reported the surgeon was performing surgery with the ezc21ta when it split at the tip and not at the top by the luer lock.There were multiple fractures between the suture hub and wire reinforcement in the hard plastic.The issue was discovered after removal of the cannula once the patient was off bypass and due to extra blood being in the field.Upon inspection after removal all the cracks and hole was noted.There was no harm to the patient for this issue and the surgery was finished.Unfortunately, the staff threw the cannula away.No photos of the cannula are available.This ezc21ta was part of the voluntary recall and the exact lot number was unknown.The voluntary recall cannulas are no longer at the facility so there can be no more use of them.

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.As the device was not returned, the complaint could not be confirmed.Root cause cannot be determined at this time.No further action is required at this time.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: EZ GLIDE AORTIC 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: 9656203
• MDR Text Key: 177755124
• Report Number: 3008500478-2020-00186
• 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: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

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: 12/15/2013
• Device Model Number: EZC21TA
• Device Catalogue Number: EZC21TA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/01/2020
• Supplement Dates Manufacturer Received: 02/10/2020; 07/23/2020
• Supplement Dates FDA Received: 03/05/2020; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention