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

Model Number EZF21A

Device Problems Failure to Align (2522); Device Markings/Labelling Problem (2911)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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 position markers indicated on the ezf21a ez glide aortic cannula bodies were not aligned with the tip orientation.Two (2) cannulas from the same lot number were noted to have the same issue.From the correct position, one cannula was about 90 degrees and the other cannula was about 45 degrees oriented differently.The cannula with 90 degrees difference was found before insertion to the patient.After that, the cannula was used with no patient adverse event.The patient is under treatment.A photo was obtained and attached to the case note.The cannula with 45 degrees difference was found in the hospital stock.

Manufacturer Narrative

Sample 1 customer report of position markers indicated on the ezf21a ez glide aortic cannula bodies were not aligned with the tip orientation was confirmed.As received, the orientation line did not align with curved tip per drawing.No other visual damage, contamination, or other abnormalities were found.Sample 2 customer report of position markers indicated on the ezf21a ez glide aortic cannula bodies were not aligned with the tip orientation was confirmed.As received, pouch remained unopened and cannula intact.As received, the orientation line did not align with curved tip per drawing.No other visual damage, contamination, or other abnormalities were found.

Manufacturer Narrative

Dhr review was completed by nordson and no relevant non-conformances were identified.Based on the information available, the reported misalignment is most likely due to manufacturing at nordson.Per the investigation conducted by nordson, four possible root causes were identified: 1) the cannula may not rotate as required during the print cycle due to lift plate dimensions tight to the cannula outer diameter dimensions.2) part drawing is not posted in the print machine station.3) no inspection points are explicitly detailed for print characteristics.4) no tooling is utilized during inspection.

Manufacturer Narrative

H10: corrected data: corrected h6.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16438585
• MDR Text Key: 310247586
• Report Number: 2015691-2023-11074
• 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,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2023

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 Model Number: EZF21A
• Device Catalogue Number: EZF21A
• Device Lot Number: 354409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/01/2023; 05/05/2023; 05/09/2023
• Supplement Dates FDA Received: 03/24/2023; 05/05/2023; 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• Patient Sequence Number: 1