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

Model Number	EZF21A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial evaluation summary - customer report of damaged suture flange was confirmed.As received, the suture flange near the tip of the cannula was observed to be chipped.The chipped piece that broke off from the suture flange was not returned with product.Brittle test (per procedure 70643 rev.F section 5.3.3) was performed on each of the remaining suture flanges; all of the flanges were found to be pliable, not brittle.A white stress mark was left on each remaining flange after brittle test evaluation.No other visible damage, contamination, or other abnormalities were observed.Photos provided appeared consistent with lab findings.The reported event has been confirmed.However, the final investigation conclusion is pending final engineering evaluation and analysis.A supplemental report will be submitted accordingly once the product 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 the suture flange of the ezf21a cannula was found chipped or deformed after cannulation to the ascending aorta during use.Due to the damage, the position of the cannula got shifted during surgery and required to fix it.It led to extension of operative time.The cannula was originally used for left ventricular tumor removal surgery.When finished after releasing the cannula clamp, mitral regurgitation appeared.Without exchanging the cannula, it was clamped again, and cardio-pulmonary bypass was started for mitral valve replacement.The cannula position was shifted then.It is unknown how long in total the cannula was used.The deformation/damage of the flange was not noticed until cannulation.The cannula was not checked prior to use.The cannula was not replaced because there was a risk of perfusion blood loss and extension of operative time.The fragment of the chipped flange was not found.The surgeon commented that the cross section of the flange appeared very smooth- if it is chipped, it would appear to be rougher.He would like to know if it was deformed or chipped.The surgeon also commented that the cannula position would not have shifted when the flange was not chipped.There was no other adverse event occurred.The patient status was reported as 'recovered'.The cannula was stored vertically at the hospital.The device will be returned for evaluation.Device photos were attached to the case note.
Additional Manufacturer Narrative
Investigation conclusions: the reported complaint was confirmed by product evaluation.No pra, scar, capa required for edwards.Per the dhr review at nordson good documentation practices were followed properly and no mrbs (non-conformities) or deviation associated to this work order were found.Based on the information available, the reported issue about the suture flange was confirmed.It was reported that the deformation/damage of the flange was not noticed until cannulation and it was not checked prior to use.Brittle test performed during returned device evaluation confirmed that the remaining three of the four flanges 'were found to be pliable, not brittle.' based on nordson's mitigations, although 100 percent visual inspection is performed prior to bonding tip component to prevent molding defects from getting into the assembly, a molding process defect cannot be over-ruled.Another likely cause of the reported issue could be physical damage caused by incorrect handling/unintended forces used during preparation or use of the device likely led to the damage/chipped flange.Based on the information available, a definitive root cause of the reported issue cannot be conclusively determined; however, manufacturing issues or handling issues during use may have contributed.Although there is not enough evidence to confirm a manufacturing non-conformance, the supplier has initiated a scar to the supplier of the flange for further investigations.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.
Additional Manufacturer Narrative
H11 corrected data- manufacturing site for devices typo corrected for city and address line 1 added.H11 manufacturer narrative: no changes in conclusions to the report.Corrections listed above are the only new information in this follow up.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.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Common Device Name: 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: 19651333
• Report Number: 2015691-2024-05004
• Device Sequence Number: 7526316
• Product Code: DWF
• UDI-Device Identifier: 00690103175080
• UDI-Public: (01)00690103175080(17)261210(11)231211(10)408635
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2024

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: EZF21A
• Device Lot Number: 408635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 09/12/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/30/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: Unknown