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

Model Number AR012

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2014

Event Type  No Answer Provided  

Event Description

It was reported by warehouse in (b)(6) that on the antegrade cardioplegia 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: fibers measure approximately 700 um to 40 um in size.The ft-ir data is consistent of polysester.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 through the edwards quality systems.

• Brand Name: ANTEGRADE CARDIOPLEGIA 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: 3630471
• MDR Text Key: 4178337
• Report Number: 3008500478-2014-00024
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113459
• 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: 01/27/2014

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 Expiration Date: 09/01/2016
• Device Model Number: AR012
• Device Lot Number: 59589921
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 01/27/2014
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 02/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• 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