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

Model Number	EZC21A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: additional manufacturer narrative: per initial product evaluation, the report of cannula leakage was confirmed.A visual evaluation indicated bonding between cannula and connector with solvent.A leak test was performed and leakage was observed between the connector to cannula junction.No other visual damage, contamination, or other abnormalities were found.The reported event is pending additional investigation and historical record review.A supplemental report will be submitted accordingly once the full investigation 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 or Problem Description
It was reported that an ezc21a from lot 419860 leaked during use 45 minutes into a cabg procedure.The product leaked at the bond section of cannula to connector.The device was reported to be used per edwards' instruction for use.Reported that there was no impact to the patient or "no adverse effects".Blood loss was minimal in that it was not measurable.The unit was stored in sterile storage "pump room" under temperature and humidity controlled conditions.No abnormalities, additional treatment or additional processing prior to use.No difficulty in connecting cannula to the circuit tubing.The traditional back bleeding of the cannula after insertion in the aorta was used to deair the cannula.The device was not exposed to any prolonged force or compression.Bypass was initiated prior to leakage - the duration of the bypass run was 84 minutes.No cable tie was used at the leakage site because it was a factory bonded connection.The perfusionist clarified that they did not recannulate/ that the device was not replaced as blood loss was minimal and a sterile towel was placed under the cannula to contain leakage.Patient was female and weight was reported as 75.5 kg.
Additional Manufacturer Narrative
The reported issue is related to a cannula leak that occurred at the connection between the cannula body and the connector.However, the incident involves a minor leakage at the junction between the ez glide cannula and the connector and there were no associated injuries or blood transfusions required.As a result, the severity of this non-conformance is limited.Therefore, this leakage issue will result only in procedural delay with no risk for the patient.Based on this information, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFEWSCIENCES 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: 20208511
• Report Number: 2015691-2024-07072
• Device Sequence Number: 15385159
• Product Code: DWF
• UDI-Device Identifier: 00690103174182
• UDI-Public: (01)00690103174182(17)270320(11)240320(10)419860
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: EZC21A
• Device Lot Number: 419860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 76 KG