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

Model Number EZS24A

Device Problems Material Discolored (1170); Gas/Air Leak (2946); Material Split, Cut or Torn (4008)

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

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Udi number:(b)(4).The device has not been returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.If additional information is received a supplemental mdr will be submitted.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 patient injury.The cannulae was exchanged before bypass was started.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 received notification that while a cannula was being used, the surgeon noted with his loops there were air bubbles in the cannula body (between the outer layer and inner layer of material) additional information was received stating that while positioning the cannula in the aorta of the patient, while de-airing the cannula,before the cpb is initiated the surgeon noticed the air bubbles within the wall of the cannula, not in the inner lumen.

Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The device not been returned therefore the event cannot be confirmed.The cause remains indeterminable at this time.If additional information is received a supplemental mdr will be submitted.

Event Description

It was learned there was no harm to the patient.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

H3.Device evaluation: customer complaint of air bubbles in the cannula body was unable to be confirmed.No bubbles were observed in the wire re-enforced region, closed coil, non-wire re-enforced region and connector/tip bonds.As received, the cannula tip was cracked and damaged.No other visible damage, contamination, or other abnormalities were observed from returned device.H10.Additional manufacturer narrative: the device was returned to edwards for evaluation.Customer complaint of air bubbles in the cannula body was unable to be confirmed.No bubbles were observed in the wire re-enforced region, closed coil, non-wire re-enforced region and connector/tip bonds.The cause of the event cannot be determined.

Event Description

The cannula was inspected before use and was not found to be cracked or damaged.

Manufacturer Narrative

Customer complaint of air bubbles in the cannula body was unable to be confirmed.No bubbles were observed in the wire re-enforced region, closed coil, non-wire re-enforced region and connector/tip bonds.As received, the cannula tip was cracked and damaged.No other visible damage, contamination, or other abnormalities were observed from returned device.The dhr was performed and no related nonconformances were found.Ezs24a cannulas are visually inspected for bubbles in the cannula body during manufacturing.Ezs24a tips are inspected for damage during receiving, assembly, and packaging.It is possible that the tip was damaged during shipment, storage, preparation, usage, or sometime after use.A definitive root cause for the air bubbles in the wall of the cannula, and the damaged cannula tip could not be conclusively determined.Based on the information available, an edwards/supplier defect has not been confirmed.

• 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: 10101934
• MDR Text Key: 207362965
• Report Number: 3008500478-2020-00197
• 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,Followup,Followup
• Report Date: 09/21/2021

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 Expiration Date: 11/21/2022
• Device Model Number: EZS24A
• Device Catalogue Number: EZS24A
• Device Lot Number: 255830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 06/01/2020; 07/23/2020; 07/23/2021; 09/15/2021
• Supplement Dates FDA Received: 06/17/2020; 01/10/2021; 08/17/2021; 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1