MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EZ GLIDE AORTIC CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EZF21A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

H10: additional manufacturer narrative: the suspect device has not yet been evaluated.The reported event is pending final evaluation analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.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

It was reported that a small amount of blood leakage between the connector and the ezf21a cannula body was noted after approximately two (2) hours of use.The specific volume of blood loss is unknown, but it was as small amount as a slow seeping out on the drape.The site was tied up with a cable tie to stop the leakage and it stopped.After that, the cannula was kept using.The cannula was laid flat on the patient.No abnormality was noted before or after the device use.It is unknown how long in total the canula was used, however, the surgeon commented that it was recovered by just tying up with a cable tie.There was no impact to the overall outcome of the procedure.There was no change in procedural strategy required due to the leakage.The patient status was reported as 'recovered'.The cannula was used for aortic root replacement, mitral valvuloplasty and coronary artery bypass graft.Connecting the cannula to the cpb tubing was not difficult.The cannula was stored flat at the hospital.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8015656209
• MDR Report Key: 18833141
• MDR Text Key: 336902631
• Report Number: 2015691-2024-01573
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZF21A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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