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

Model Number DCT

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: customer report that a "white particulate was noticed inside the cannula" was confirmed.Upon closer examination of the particulate, it was found that the clear particulate was actually embedded within the non-wired reinforced section of the cannula body.The particulate was found to be embedded in the cannula body material under 3x magnification in less than 30 seconds.The embedded in product particulate was measured to be < 1.5 mm², which is within specification.No other visual damage, contamination, or other abnormalities were found to the device.The device was returned to edwards for evaluation.The device history record (dhr) was unable to be reviewed as the lot number is unknown.Manufacturing imperfections may be present in the wall of a cannula due to the manufacturing process.Since they are contained within the wall of the cannula, there is no risk of it impacting the performance of the device.Potential for injury is remote.However, in this case, the cannula was connected to the patient.In this case, the surgeon had to replace the cannula after noticing a particulate (most likely a bubble) in the distal end of the cannula.Based on the information received the cause of the event cannot be determined.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported that a white particulate was noticed inside the cannula at the distal side before pumping after connecting the cannula to the patient.The cannula was removed, and another cannula was used.The doctor commented that the particulate appeared to be moving, however, after removing the cannula, it was confirmed that the particulate did not move and was not in the fluid path.It seemed to be a bubble within the cannula body wall.The patient status was reported as ¿recovered¿.There were no patient complications reported.The size of the particulate was approximately 1mm.

Manufacturer Narrative

Manufacturing, supplier, design, ifu, and labeling defects were not confirmed.Device was returned and complaint of embedded particulate was confirmed.Particulate was within specifications; no defect was identified.Trend is out of control.Capa and pra action are not required.

Manufacturer Narrative

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: 9649345
• MDR Text Key: 194927315
• Report Number: 3008500478-2020-00185
• 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,Followup
• Report Date: 01/06/2020

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 Model Number: DCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 02/20/2020; 07/23/2020
• Supplement Dates FDA Received: 03/05/2020; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR