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

Model Number	EZC24TA
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
These devices are inserted into the blood vessels during cardiac surgery.Cracks in the material may lead to loose fragments in the vasculature which could embolize distally and cause infarction.The device was returned and product evaluation is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported that the vented connector of a ez glide aortic cannula came loose and the distal tip had a crack.There were no patient injuries.Per rep this was a cabg procedure and the event occurred towards the end of the procedure.No exchange of cannula was required.No abnormality of the device or packaging was noted prior to use.
Additional Manufacturer Narrative
Based on the information available, the complaint of cracked tip is confirmed, however, the most likely cause is due to excessive force applied by the user.An edwards defect has not been confirmed.
Event or Problem Description
It was reported that the tip of a ezc24ta ez glide aortic cannula was cracked.There were no patient injuries.Per rep this was a cabg procedure and the event occurred towards the end of the procedure.No exchange of cannula was required.No abnormality of the device or packaging was noted prior to use.Per the perfusionist the it came loose at the red-cap.It has to deal with the bonded vent connector site.The perfusionist feels the issue lies within the small vent connector barb and recommends a three barb connector.
Additional Manufacturer Narrative
Updated b5 per new information received.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14959177
• Report Number: 2015691-2022-06684
• Device Sequence Number: 20182485
• Product Code: DWF
• UDI-Device Identifier: 00690103714418
• UDI-Public: (01)00690103714418(17)241024(11)211025(10)328572
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2024
• Device Model Number: EZC24TA
• Device Catalogue Number: EZC24TA
• Device Lot Number: 328572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 09/21/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 07/26/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown