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

Model Number EZC21TA

Device Problems Device Slipped (1584); Separation Problem (4043)

Patient Problem Blood Loss (2597)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to edwards for evaluation.Evaluation is in progress.Based on the information received the cause of the event cannot be determined.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported that the connector of the ezc21ta ez glide cannula slipped out during rewarming period, causing breach of circuit and loss of blood (0.5 l).Patient outcome was stable.As reported the surgeon has extensive experience of using this device.The disconnect was at the cannula body to barbed connector.However, the connector is not barbed at this connection, only to the end eventually connected to the atrial line from the heart lung machine.The customer commented that the available space at this connection for bonding material seemed a bit limited.

Event Description

It was reported that the connector of the ezc21ta ez glide cannula slipped out during the rewarming period, causing a breach of circuit and loss of blood (0.5 l).As reported the surgeon has extensive experience of using this device.The disconnect was at the cannula body to the molded/bonded [non-barbed] tip of the connector.The customer commented that the available space at this connection for bonding material seemed a bit limited.The issue occurred near the end of the case, and there was nothing unusual about the case.There was no unusual stress placed on the cannula.Although the physician was able to clamp the cannula quickly, he thought it best to give the patient some blood.The case was successful and the patient was discharged doing well.

Manufacturer Narrative

Edwards received additional information through follow-up with the healthcare provider.Updated b5 to include additional information and updated verbiage.An engineering evaluation was completed and a manufacturing defect was confirmed.Further investigation was initiated to determine the root cause of the issue and perform any necessary corrective actions.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.

Manufacturer Narrative

H10.Additional manufacturer narrative: edwards received additional information through follow up with the healthcare provider.Supplemental report submitted to update b5 and device evaluation.Updated h7.Field corrective action (fca-146) has been initiated for the ez glide cannula separation issue.The device was returned for evaluation and the customer report of separated connector from ez glide cannula was confirmed.As received, the connector end of the cannula was separated from main cannula body.Indications of what appeared to be bonding material were found on both the detached connector end and the cannula body end.No other visual damage, contamination, or other abnormalities were found to the device.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.An engineering evaluation has been initiated for further investigation.A supplemental report will be submitted upon completion.

Event Description

Edwards received additional information through follow up with the healthcare provider that the patient received blood immediately following the incident.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: AORTIC PERFUSION CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9046060
• MDR Text Key: 161307034
• Report Number: 3008500478-2019-00158
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2019

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 Expiration Date: 12/12/2021
• Device Model Number: EZC21TA
• Device Catalogue Number: EZC21TA
• Device Lot Number: 224662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 10/10/2019; 11/14/2019; 07/23/2020
• Supplement Dates FDA Received: 11/04/2019; 11/18/2019; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention