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

Model Number EZS21QTA

Device Problem Particulates (1451)

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

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device evaluation revealed two pieces of unknown loose particulate found within the cannula lumen.The particulates were evaluated by ft-ir analysis.Sample #1 most closely correlated with polyester with a length of approximately 780 micrometers.Sample #2 most closely correlated with polypropylene with a sample area measuring 6,300,000 micrometers squared.Additional investigation is underway.Additional information will be provided in a supplemental report.

Event Description

Edwards received information that after passing an aortic cannula into the sterile field, plastic debris was noted inside the cannula.The cannula was not used.

Manufacturer Narrative

A manufacturing related defect was confirmed.Additional investigation for root cause and implementation of corrective action is underway through edwards quality system.The device history record (dhr) was reviewed, and showed this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Trends will continue to be monitored through the use of edwards quality systems.

• 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 ; one edwards way; m/s t&d 2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5683603
• MDR Text Key: 46066268
• Report Number: 3008500478-2016-00018
• 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: 05/13/2016

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 Expiration Date: 10/01/2018
• Device Model Number: EZS21QTA
• Device Lot Number: 60193810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2016
• 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