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

Model Number EZC24TA

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2022

Event Type  Injury  

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 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.

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 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.

Manufacturer Narrative

Updated b5 per new information received.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: 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
• MDR Text Key: 295596538
• Report Number: 2015691-2022-06684
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00690103714418
• UDI-Public: (01)00690103714418(17)241024(11)211025(10)328572
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/01/2022; 09/21/2022
• Supplement Dates FDA Received: 07/26/2022; 09/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening