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

Model Number DEZS21TA

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to edwards for evaluation as is pending evaluation.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported a ezs21ta cannula leaked from the seam of the luer connector.Per perfusionist, they had to come off bypass, cut the connector out, and place a new connector, and then resume bypass.

Manufacturer Narrative

Device evaluation: customer report of cannula leaked from the seam of the luer connector was unable to be confirmed in the as received condition.As received, cannula body was observed to be cut-off at the non-wire reinforced section of 0.6 in distal from the connector.Cross surfaces appeared uneven and rough.Cannula body was not returned.No other visual damage, contamination, or other abnormalities were found on the connector.

Manufacturer Narrative

Added information to b5, h6, dhr review was performed, and no relevant non-conformances were identified.No other similar complaints were found per the lot history review.Based on the information available, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined.An edwards defect has not been confirmed.

Event Description

It was reported a 21mm ez glide aortic cannula leaked from the seam of the luer connector at the beginning of the case, just after bypass was initiated.Per the perfusionist, they had to come off bypass, cut the connector out, and place a new connector, and then resume bypass.The crack seemed to stem from the luer.The cannula was in use for only a few minutes before it started to leak.There was significant leakage, the attending surgeon was sprayed quite significantly.The exact pressures are unknown, but customer reports alarm is set to 300 mmhg, and the alarm was not triggered.Reported the pressures usually run in the upper 100s to low 200s.Patient outcome was as expected.

• Brand Name: EZ GLIDE AORTIC PERFUSION 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: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17687441
• MDR Text Key: 322695992
• Report Number: 2015691-2023-15731
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00690103172102
• UDI-Public: (01)00690103172102(17)260307(11)230308(10)378826
• 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: 12/01/2023

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: DEZS21TA
• Device Lot Number: 378826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/15/2023; 11/15/2023
• Supplement Dates FDA Received: 10/10/2023; 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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): Life Threatening; Hospitalization; Required Intervention