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

Model Number DCT21A

Device Problem Particulates (1451)

Patient Problem Not Applicable (3189)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: during visual examination, it was determined that a loose particulate was found stuck inside the lumen of the device.The particulate was analyzed and was identified to be polyvinyl chloride #4 like material with an area measurement of 2,675,970 micro meter squared.Further investigation is being conducted.A supplemental will be submitted when the additional investigation is complete.

Event Description

It was reported by edwards internal customer that an unknown embedded clear material was found in the wire- reinforced section of an arterial cannula body during incoming inspection.

Manufacturer Narrative

Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.Corrective and preventative actions were taken.

• Brand Name: DISPERSION TIP 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; 1 edwards way; irivne CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms t&d2; irivne, CA 92614 ; 9492502289
• MDR Report Key: 5880934
• MDR Text Key: 52279146
• Report Number: 3008500478-2016-00027
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

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: 04/01/2019
• Device Model Number: DCT21A
• Device Lot Number: 60379680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2016
• 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