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

Model Number EZF21A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

H10: additional manufacturer narrative: the suspect device has not yet been evaluated.The reported event is pending final 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.

Event Description

It was reported that a small amount of blood leakage between the connector and the ezf21a cannula body was noted after approximately two (2) hours of use.The specific volume of blood loss is unknown, but it was as small amount as a slow seeping out on the drape.The site was tied up with a cable tie to stop the leakage and it stopped.After that, the cannula was kept using.The cannula was laid flat on the patient.No abnormality was noted before or after the device use.It is unknown how long in total the canula was used, however, the surgeon commented that it was recovered by just tying up with a cable tie.There was no impact to the overall outcome of the procedure.There was no change in procedural strategy required due to the leakage.The patient status was reported as 'recovered'.The cannula was used for aortic root replacement, mitral valvuloplasty and coronary artery bypass graft.Connecting the cannula to the cpb tubing was not difficult.The cannula was stored flat at the hospital.

Manufacturer Narrative

H11 updated/ corrected- g3(awareness date), g6(follow up information), h2(follow up type), h3 (evaluation), h4 (manufacturing date), h6 codes: type of investigation codes, investigation findings code, and investigation conclusion codes.H11 additional narrative/ data from the evaluation performed per h3- per the product investigation engineering evaluation summary, the complaint of leakage was not confirmed upon return.Ifu/ labelling is adequate and no corrective action is required at this time.There is no evidence to suggest an edwards/supplier manufacturing defect.Per product evaluation, the report of cannula leakage was unable to be confirmed during product evaluation.Device was returned with visible blood residue at the connector to cannula junction and the barb connector to tubing junction.Two cable ties were observed on both junctions.[internal documentation] indicated bonding between cannula and connector with solvent.A leak test was performed on the as received cannula and with cable ties removed and no leakage was observed between the connector to cannula junction and the connector to tubing junction.Per ifu, [securely tie-band the connector to cannula junction prior to initiating bypass to protect against tubing slippage] and [connect to circuit tubing and securely tie-band all line connections].No visual damage, contamination, or other abnormalities were found.Per supplier dhr review and investigation, this support issue was not confirmed by nordson medical.The dhr review was completed; the supplier confirmed that good documentation practices were followed properly and no mrbs (non-conformities) or deviation associated to this work order were found.Retain sample stored in guaymas facility of work order has been evaluated.No abnormal condition was found, connector bonded in cannula have no visual damage nor cracks in barbed section.Component used in work order is considered acceptable based on current acceptance criteria.In reviewing statistical process control, the tensile test results of connector bonding work order meets the acceptance criteria.Samples were analyzed and accepted.In summary, the reported complaint was unable to be confirmed with assessment.Based on the information available, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined.An edwards/ supplier defect has not been confirmed.Edwards will continue to monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8015656209
• MDR Report Key: 18833141
• MDR Text Key: 336902631
• Report Number: 2015691-2024-01573
• 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
• Report Date: 05/07/2024

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: EZF21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2023
• 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