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

Model Number EZS24TA

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 05/05/2022

Event Type  malfunction  

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 when flushing an ezs24ta ez glide aortic cannula a white, crumbly, powdery substance was noticed coming out of the cannula into the basin.The substance was noted to be possibly some kind of plastic debris from either the cannula or the pruits that were flushed.It was later thought that the hydrophobic filter in the cap had crumbled.It was then decided to switch cannulae at this point.The same model but different lot was used and no issues were observed.The original subject cannula was never used to pump into the aorta.The cannula and cap were saved to be returned.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (component code, type of investigation, investigation findings, investigation conclusions) it was reported that an unknown white-colored particulate was found inside the ez glide aortic cannula during preparation before use.The device was not used.There were no patient complications reported.Per evaluation, no other visual damage, contamination, or other abnormalities were found to the device.Photo provided of particulates was not consistent with lab findings; particulates were not present on the returned device.The root cause of this event cannot be conclusively determined with the available information.There was no device problem 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.H11: corrected data: h3 (evaluation summary): customer complaint of an 'a white, crumbly, powdery substance was noticed coming out of the cannula' was unable to be confirmed.Device was returned with visible traces of blood.Returned device was examined by two lab personnel; reported loose particulate could not be found in the as received condition.Per ifu, 'keep the vent plug dry prior to use.The porous vent plug is designed to vent air when dry and may not function as intended if wet.' vent plug was returned with visible traces of blood on surface and inside of vent plug.Report of crumbled hydrophobic filter was not confirmed; vent plug remained intact.No other visual damage, contamination, or other abnormalities were found to the device.Photo provided of particulates was not consistent with lab findings; particulates were not present on returned device.

Manufacturer Narrative

H3: evaluation summary: customer complaint of an "a white, crumbly, powdery substance was noticed coming out of the cannula" was unable to be confirmed.Device was returned with visible traces of blood.Returned device was examined by two lab personnel; reported loose particulate could not be found in the as received condition.Vent plug was returned with visible traces of blood on surface and inside of vent plug.Report of crumbled hydrophobic filter was not confirmed; vent plug remained intact.No other visual damage, contamination, or other abnormalities were found to the device.

• 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 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14526915
• MDR Text Key: 300594561
• Report Number: 2015691-2022-05961
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2022

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 Expiration Date: 07/16/2023
• Device Model Number: EZS24TA
• Device Catalogue Number: EZS24TA
• Device Lot Number: 276283
• 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: 05/05/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 07/14/2022; 08/12/2022
• Supplement Dates FDA Received: 08/08/2022; 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2020
• Patient Sequence Number: 1