MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSI; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number ARL2011STA

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

There is insufficient information to conclusively determine the root cause of this event.It is unknown if excess force was used that may have contributed to the event.The product has not been returned for evaluation.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received notification that after removing the red cap of the perfusion cannula device, the cannula was connected to the cpb tube.It was then noticed that the connector of the cannula was damaged at its tip, in the outer distal side, and a piece of the same was missing.The surgeon decided to proceed with the procedure, which concluded with no issue.As reported the surgical team was experienced in using this cannula (more than 10 years) and handled the product properly.The device was not hit nor aggressive movements were done with the cannula.Reportedly, when the packaging was opened, the cannula cap was correctly placed.There was no bleeding and no extra bubbles due to the use of the device.There was no impact to the patient.It was noted that the patient has been discharged.

Manufacturer Narrative

Customer report that "the connector of the cannula was damaged in the outer distal side" was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.The connector side of the cannula was observed to be damaged with a dent.The connector was not broken and no missing parts were observed.No other visual damage, contamination, or other abnormalities were found to the device.Photos provided by the edwards representative appeared consistent with lab findings.There is insufficient information to conclusively determine the root cause of this event.It is unknown if excess force was used that may have contributed to the event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

Manufacturer Narrative

H11.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSI
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7681468
• MDR Text Key: 114153413
• Report Number: 3008500478-2018-00073
• 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: 06/19/2018

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: 04/04/2020
• Device Model Number: ARL2011STA
• Device Catalogue Number: ARL2011STA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 09/14/2018; 11/16/2020
• Supplement Dates FDA Received: 09/17/2018; 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR