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

Model Number EZF21A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2014

Event Type  No Answer Provided  

Event Description

It was reported by warehouse in (b)(4) that the ez glide aortic cannula "hair contamination was found inside the package during incoming inspection." this was found during (b)(4) incoming inspection and never had contact with the patient/hospital.

Manufacturer Narrative

The device evaluation is currently in process into root cause.

Manufacturer Narrative

Evaluation: a loose black fiber was found and the analysis was consistant with rayon.This report is a confirmed manufacturing defect.Edwards has iniatied a pra and capa to investigate this event.Edwards has a technical summary to discuss the product safety risk adn analysis of ongoing investigation work.Trends will continue to be monitored through the edwards quality system.

• Brand Name: EZGLIDE AORTIC 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: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3691370
• MDR Text Key: 16685852
• Report Number: 3008500478-2014-00040
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2014

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: Other
• Device Expiration Date: 01/01/2017
• Device Model Number: EZF21A
• Device Lot Number: 59679155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2014
• Device Age: 1 MO
• Date Report to Manufacturer: 02/25/2014
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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