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

Model Number	EZC21TA
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6) y.O.Male undergoing cardiac surgery.~2hrs into procedure, aortic cannula suddenly disconnected at the pre-fabricated connection site on the cannula adjacent to cpb tubing connection.Surgical team immediately created new connection & was able to fill cannula to avoid entry of any air.Procedure completed.No patient harm or adverse effect noted at this time.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC
• MDR Report Key: 8912691
• Report Number: MW5089201
• Device Sequence Number: 11451349
• Product Code: DWF
• UDI-Device Identifier: 00690103174199
• UDI-Public: (01)00690103174199
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: EZC21TA
• Device Catalogue Number: REF# EXC21TA
• Device Lot Number: 224662
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 79