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

Model Number EZS24QTA

Device Problems Material Discolored (1170); Gas/Air Leak (2946)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned to edwards for evaluation.Attempts to retrieve the devices and additional information were unsuccessful.If additional information is received a supplemental mdr will be submitted.The device history record (dhr) reviews could not be performed as the lot numbers are unknown.The reported event could not be confirmed.During venting, some microbubbles may persist; this is typically due to user technique and not related to the manufacturing or design of the cannula.Air in the arterial system has the potential to embolize to the brain.The presence of micro bubbles, while unlikely to result in a serious neurological event, may prolong the cognitive recovery after bypass surgery.In this case, there was no reported patient injuries.The cause of the event cannot be determined.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

Edwards was aware that during use of an unknown number of aortic cannulae, the surgeon noted air bubbles in the cannula.As reported, the bubbles were noted during the de-airing process and the surgeon had difficulties to discern if the observed air bubbles were in the inner lumen/blood flow or within the wall of the cannula (i.E.Between the outer and the inner layer).At the time of each event, the surgeon did not feel that reporting was needed however, after noticing the issue a few times, he felt that it was a recurrent issue and that it needed to be reported because it could bring confusion in the de-airing process.The surgeon cannot recall specific details of these cases (total number of cases, occurrence date, cannula size, lot numbers ¿).No injury to patients has been reported.

Manufacturer Narrative

H10.Additional manufacturer narrative: added information to b5.The devices are not available for evaluation.The lot numbers of the cannulae remain are unavailable.The reported events cannot be confirmed and cause remains indeterminable.

Event Description

Edwards learned that for approximately three months ago during use 3-5 times using the cannula (21 or 24fr) the surgeon noted air bubbles in the cannula.All the cannulas were used for the entire procedure with no injury for the patients.

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 10116346
• MDR Text Key: 207363978
• Report Number: 3008500478-2020-00198
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2020

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 Model Number: EZS24QTA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 06/01/2020; 07/23/2020
• Supplement Dates FDA Received: 06/17/2020; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1