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

Model Number AR014V

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  No Answer Provided  

Event Description

It was reported by the edwards warehouse in (b)(4) that "unknown black fiber-like particulate was found inside the package during incoming inspection.".

Manufacturer Narrative

Device particulate is currently under evaluation into root cause.

Manufacturer Narrative

Evaluation: the particulate was evaluated and was found to measure approximately 20m by 350m in size.The ft-ir data is consistent with nylon.This report is a confirmed manufacturing defect and root cause is being addressed through capa.Manufacturing records were reviewed and there were no related manufacturing non-conformances.A technical summary has been initiated to address patient safety risk and to summarize the analysis of returned products to assist in ongoing corrective actions.Instructions for use remain appropriate.Trends will continue to be monitored by through the edwards quality systems.

• Brand Name: AORTIC ROOT 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: walter wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3685550
• MDR Text Key: 4289444
• Report Number: 3008500478-2014-00035
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2014

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: Health Professional
• Device Model Number: AR014V
• Device Lot Number: 59665423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2014
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2014
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2014
• 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