MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULAE; AORTIC PERFUSION CANNULAE

Model Number EZC21A

Device Problems Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The evaluation is anticipated but has not yet begun.A supplemental report will be submitted upon completion.

Event Description

It was reported that a black particulate was found inside cannula when opening the package before use.The size of the particulate was 2-3 mm, and it was likely to be the ew logo which was printed on the outside of this cannula.There were no patient complications reported.

Manufacturer Narrative

Japan warehouse complaint of "black particulate" was confirmed.As received, an unknown loose black particulate was found already isolated from the cannula.As received, the device appeared to have incomplete printing on the wired reinforced section of the cannula.Upon examination, the non-wired section of the cannula appeared to have unknown contaminates.Device was sent to chemistry lab for ft-ir analysis.No other visual damage, contamination, or other abnormalities were found to the device.Engineering task has been opened and assigned for further investigation.A supplemental report will be submitted.

Manufacturer Narrative

Device was sent to chemistry lab for ft-ir analysis.The particulate was removed from the sample slide and scanned by diamond atr.Particulate was broken into two pieces, measuring at 1674 m by 640 m for an area measurement of 1,071,360 m² and 1446 m by 678 m for an area measurement of 980,388 m².The ft-ir spectrum showed similar absorption characteristics to acrylic polymer like material.The complaint is confirmed.Per the product evaluation and chemistry evaluation, the complaint of "black particulate" was confirmed.Per the engineering evaluation, a manufacturing defect was confirmed.A supplier, design, ifu, and labeling defect were not confirmed.The trend is in control and the fmea line item is appropriate.Pra was initiated and the root cause will be investigated in capa.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EZ GLIDE AORTIC CANNULAE
• Type of Device: AORTIC PERFUSION CANNULAE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8793708
• MDR Text Key: 151328429
• Report Number: 3008500478-2019-00151
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2019

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: EZC21A
• Device Catalogue Number: EZC21A
• Device Lot Number: 61438670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 09/16/2019; 07/23/2020
• Supplement Dates FDA Received: 08/22/2019; 09/24/2019; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1