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

Model Number DCT21A

Device Problems Material Discolored (1170); Material Too Rigid or Stiff (1544)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: customer report that "cannula body was found discolored into yellowish color" was confirmed.As received, the cannula was observed to be opaque and discolored in a yellowish tinge when compared with a lab sample cannula.Water was added to the cannula and air bubbles could not be seen through the non-wire reinforced section of the cannula body where the greatest opacity was observed.No other visible damage, contamination, or other abnormalities were observed from returned device.Discoloration 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.In this case, the root cause of this event cannot be determined at this time.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that the cannula body was found discolored into a yellowish color when the package was opened before use.The doctor commented that he felt the cannula was harder than usual.The device was not used for the patient.There were no patient complications reported.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: AORTIC PERFUSION 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: 8533730
• MDR Text Key: 142755287
• Report Number: 3008500478-2019-00126
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

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: 09/13/2020
• Device Model Number: DCT21A
• Device Catalogue Number: DCT21A
• Device Lot Number: 61053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 09/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1