MAUDE Adverse Event Report: EDWARDS LIFESCIENCE, LLC EZ GLIDE AORTIC CANNULA; CATHETER, CANNULA AND TUBING

Catalog Number EZC24TA

Device Problem Break (1069)

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

Event Date 01/02/2019

Event Type  malfunction  

Event Description

While cannulating a small chip on the connecting end of the aortic cannula was noticed.However, there did not appear to be any loose pieces.The cannula continued to be used during the case and did work properly.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING
• Manufacturer (Section D): EDWARDS LIFESCIENCE, LLC; one edwards way; irvine CA 92614
• MDR Report Key: 8273167
• MDR Text Key: 133946916
• Report Number: 8273167
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/03/2019

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 Catalogue Number: EZC24TA
• Device Lot Number: 61438663
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Weight: 79