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

Model Number EZC21A

Device Problem Break (1069)

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

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: additional investigation is underway.Additional information will be provided in a supplemental report.

Event Description

Edwards received information that a the tip of an aortic cannula broke off while being placed.There were no issues for the patient.Upon follow-up it was reported that the tip broke at the suture bump prior to going on bypass.The surgeon was a very experienced user of the device.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned to edwards for evaluation and the complaint condition was confirmed.As received, the cannula tip was found broken off from the cannula at the suture bump.A cross surface of the broken areas appeared uneven and rough.Edges of broken pieces matched up.No other visible damage, contamination, or other abnormalities were observed from returned device.Manufacturing records were unable to be reviewed as not lot number was provided.A supplier manufacturing defect was not identified.Based on the information received and product evaluation finding, a definitive root cause could not be confirmed.The fmea adequately addressed potential causes of failure and the associated hazards.The complaint trend was assessed and it was found to be in control.No further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

• Brand Name: EZ GLIDE AORTIC PERFUSION CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: neil landry ; 1 edwards way; m/s t&d 2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5822579
• MDR Text Key: 50452908
• Report Number: 3008500478-2016-00022
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

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 Model Number: EZC21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1