MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULA; ARTERIAL CANNULAE

Model Number EZC21A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss.The potential for serious injury before or during use is not remote.The product evaluation has not started.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received information that the connector of an arterial cannulae was broken while cannulating before the initiation of bypass.The connector was suddenly broken during purging air and blood spurted from there.The customer immediately covered the broken site with his hand to stop blood spurt, and cut the cannula body at approximately 5mm from the edwards logo on the connector side while clamping it with forceps, and connected the cannula directly to the tube of the cardiopulmonary bypass circuit.After that, the operation was successfully completed without any problems.The patient status was reported as 'recovering'.There were no visible abnormalities/problems founded prior to use.The device was stored horizontally on the shelf in the storage room at the hospital.The device was returned for evaluation.Although the amount of blood spurted was not provided, there were no patient complications reported.The customer commented that the connector of the cannula may have been accidentally tapped when purging air.

Manufacturer Narrative

Updated section h6.Complaint is confirmed.Based on the video and provided information, it is likely that the broken connector resulted from excessive tapping and mishandling of the connector during use.

Manufacturer Narrative

H10: additional narratives.Updated b5, d4, d9, h3, h4, and h6 per new information received.H3: product evaluation.Customer report of 'the connector of an ezc21a was broken' was confirmed.As received, the barb section of the connector was broken off.A 1' section of tubing was attached to the barb connector.The two broken sections appeared to match up.Cross surfaces of broken connector appeared uneven and rough.Cannula body was observed to be cut-off at the non-wire reinforced section 0.5" distal from the connector and appeared to match up.No other visual damage, contamination, or other abnormalities were found.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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 information that the connector of an arterial cannulae was broken while cannulating before the initiation of bypass.The connector was suddenly broken during purging air and blood spurted from there.The customer immediately covered the broken site with his hand to stop blood spurt, and cut the cannula body at approximately 5mm from the edwards logo on the connector side while clamping it with forceps, and connected the cannula directly to the tube of the cardiopulmonary bypass circuit.After that, the operation was successfully completed without any problems.The patient status was reported as 'recovering'.There were no visible abnormalities/problems founded prior to use.The device was stored horizontally on the shelf in the storage room at the hospital.Although the amount of blood spurted was not provided, there were no patient complications reported.The customer commented that the connector of the cannula may have been accidentally tapped when purging air.The surgery video showed that the connector of the cannula was strongly tapped with forceps quite a few times to purge air.Per the product evaluation, the barb section of the connector was broken off.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: ARTERIAL CANNULAE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11555410
• MDR Text Key: 244033317
• Report Number: 2015691-2021-02024
• 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: 06/02/2021

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: 03/02/2023
• Device Model Number: EZC21A
• Device Catalogue Number: EZC21A
• Device Lot Number: 264723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/12/2021; 06/02/2021
• Supplement Dates FDA Received: 05/07/2021; 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention