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

Model Number TF034L

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

Discoloration of a cannula is caused by the heat in the cure process.There is some variation of heat stability between each lot of plastisol material, which is why some cannulae show variation in coloration and others do not.This is typical in the dip molding process.It is also possible to have color variation between different segments of the same cannula.The variation in coloration is considered cosmetic only and poses no risk to the patient.In this case, it was reported the cannula's original transparent color changed to a white color and reduced cannula visibility during bypass.The potential for serious injury is not remote.The root cause of this event cannot be conclusively determined with the available information.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification that after a few hours of surgery, there was a change in the color of this edwards single stage venous cannula (tf034l).The issue was observed by the surgeon.As reported, cannula's original transparent color was changed to white color reducing cannula visibility.It was the first use for this cannula.Duration of product use was about 4 hours.Planned procedure was a cabg and mvr.The product was handled as usual.The patient was noted to be stable after the procedure.The device was not returned for evaluation as it was discarded a the site. surgeon with 5 years of experience with this device.

• Brand Name: VENOUS CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10495115
• MDR Text Key: 207293078
• Report Number: 3008500478-2020-00206
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

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: 04/03/2022
• Device Model Number: TF034L
• Device Catalogue Number: TF034L
• Device Lot Number: 234419
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR