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

Model Number EZC21A

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

It was reported that the connector of ezc21a ez glide aortic cannula got torn and got detached from the tubing of extracorporeal circulation after the cannula insertion.The location of the torn site was the connector near the barbed end.The separation of cannula connector was before initiation of bypass.The cannula at non-reinforced site was cut, clamped right away, and there was almost no blood leakage.New connector was inserted to the cannula's non-reinforced site, and re-connected to the extracorporeal circulation tubing.No patient complications related to interruption of bypass.There was no changes in procedural strategy due to interruption.The cannula was laying straight.There was no laxity noted at time of connection.The patient status was reported as recovered.The device was stored flat at the hospital.The customer commented that they attempted to vent air from the cannula by tapping the cannula body with forceps.It is a normal deairing technique, and there was no excessive tapping involved.They did not tap the connector area then.Excessive force was required to connect the tubing.There was no pharmacological solutions present in the circuit.The device was used for thoracic aortic aneurysm surgery, mitral valvuloplasty, and coronary artery bypass graft.

Manufacturer Narrative

H10: additional manufacturer narrative: the reported event is pending return and evaluation analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

H11 manufacturer narrative: g3 awareness date and g6 follow up number updated.H1/h2 information for follow up report filled out.H6 type of investigation codes updated.Investigation conclusion codes remain the same as preceding follow up report.H11 additional/ corrective information added below for supplemental report: the manufacturer supplied additional information regarding the investigation.Engineering summary has been updated with the additional information and the conclusion updated as follows- this problem has not been traced to manufacturing.Based on the information available, the complaint of connector detachment/damage is confirmed.However, the most likely cause is traced to known inherent risk of device - random component failure.Most likely source of physical damage was due to handling of device.Customer states that, '.They attempted to vent air from the cannula by tapping the cannula body with forceps.', per the instructions for use, 'do not hit with hard objects, such as forceps, etc.During removal of air bubbles.' the manufacturer attempted to try to replicate the failure by applying excessive force and manipulation of the device while connecting the device and was unable to replicate the failure mode.It is possible that customer tapping device to de-air may have contributed to the reported event, but this cannot be conclusively determined.An edwards/supplier defect has not been confirmed.

Manufacturer Narrative

H10 additional manufacturer narrative: updated sections b4(date of report), b5(event description), d9 (device available and return date), g3(date new information received), h3, h4, and h6 (type of investigation, investigation findings, investigation conclusions) per product evaluation, customer report of connector detached from tubing was confirmed.As received, the cannula was connected to a barb connector, proximal end of cannula appeared to be cut.Another barb connector was received detached from the cannula and broken at the barb end.An approximately 1 inch section of tubing was attached to the barb connector end and approximately 0.4 inch section of cannula body at the distal end.The two broken sections of connector 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 1 inch distal from the connector and cut cannula body appeared to match up.No other visual damage, contamination, or other abnormalities were found.Per dhr review, dhr review was completed, as result of this investigation for order number (b)(4), pn 10019254021, product description 'ezc21a' could confirmed that good documentation practices were followed properly and no non-conformities or deviation associated to this work order were found.Mitigations and controls are in place at the manufacturer.Per engineering evaluation summary, this problem has not been traced to manufacturing.Based on the information available, the complaint of connector detachment/damage is confirmed.However, the most likely cause is traced to known inherent risk of device - random component failure.Most likely source of physical damage was due to handling of device.Customer states that, '.They attempted to vent air from the cannula by tapping the cannula body with forceps.', per instructions for use, 'do not hit with hard objects, such as forceps, etc.During removal of air bubbles.'.It is possible that customer tapping device to de-air may have contributed to the reported event, but this cannot be conclusively determined.An edwards or supplier defect has not been confirmed.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that the connector of ezc21a ez glide aortic cannula got torn and got detached from the tubing of extracorporeal circulation after the cannula insertion.The location of the torn site was the connector near the barbed end.The separation of cannula connector was before initiation of bypass.The cannula at non-reinforced site was cut, clamped right away, and there was almost no blood leakage.New connector was inserted to the cannula's non-reinforced site, and re-connected to the extracorporeal circulation tubing.No patient complications related to interruption of bypass.There was no changes in procedural strategy due to interruption.The cannula was laying straight.There was no laxity noted at time of connection.The patient status was reported as 'recovered'.The device in pieces will be returned for evaluation.Photo which was taken at total distribution center was attached.The device was stored flat at the hospital.The customer commented that they attempted to vent air from the cannula by tapping the cannula body with forceps.It is a normal deairing technique, and there was no excessive tapping involved.They did not tap the connector area then.There was no pharmacological solutions present in the circuit.The device was used for thoracic aortic aneurysm surgery, mitral valvuloplasty, and coronary artery bypass graft.Product evaluation: customer report of connector detached from tubing was confirmed.The two broken sections of connector appeared to match up.Cross surfaces of broken connector appeared uneven and rough.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8018424930
• MDR Report Key: 18655813
• MDR Text Key: 334732762
• Report Number: 2015691-2024-00803
• Device Sequence Number: 1
• Product Code: DWF
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZC21A
• Device Catalogue Number: EZC21A
• Device Lot Number: 362461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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