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

Model Number EZF21A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/27/2021

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 by the warehouse in japan that an unknown black substance was found on the wire reinforced section of the ez glide cannula body during incoming inspection.No other details were provided.

Manufacturer Narrative

H3: evaluation summary: customer report that an 'unknown black substance was found on the wire reinforced section of the ez glide cannula body' was confirmed.A black particulate was found embedded within the wired reinforced section of the cannula body.The particulate was measured to be 0.60 mm2, which is within specification per procedure.Specification states that for particles in product, two particulate is allowable when <0.80 mm2.No other visual damage, contamination, or other abnormalities were found to the device.Photo attached by complaint handler appeared consistent with lab findings.H10: additional manufacturer narrative: the reported event was confirmed through preliminary evaluation of the device.The device has been sent for further testing and analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.

Manufacturer Narrative

H10: additional manufacturer narrative: upon evaluation, even though the presence of the black particular was confirmed, but the particulate was within specification.It was determined that there was no defect found.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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, AORTIC PERFUSION CANNULA WITH DURAFLO COATING
• 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 LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13321758
• MDR Text Key: 284372139
• Report Number: 2015691-2022-03628
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2022

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
• Device Catalogue Number: EZF21A
• Device Lot Number: 319847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 02/10/2022; 03/30/2022
• Supplement Dates FDA Received: 03/04/2022; 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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