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

Model Number EZS21TA

Device Problems Contamination /Decontamination Problem (2895); Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The device was returned to edwards for evaluation.Evaluation is in progress.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.A manufacturing related issue was not identified.Once device evaluation is complete, a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a scrub tech discovered "two dots" on the tip of an aortic cannula before use.The perfusionist handed the cannula to the scrub tech and the scrub tech noticed the imperfections.The "dots" were reported to be in the fluid path.The cannula never got to the surgeon.The "two dots" were circled in black sharpie in a provided photo.

Manufacturer Narrative

Reference (b)(4).

Manufacturer Narrative

H3.Device evaluation: customer complaint of "dots on the tip of an aortic cannula" was confirmed.Unknown loose red-yellow particulates were found on the the tip of the cannula under 3x magnification in less than 30 seconds.The particulate was removed from the sample slide and scanned by diamond atr.Particulate was broken into two pieces, measuring at 1161m by 339m for an area measurement of 393,579m² and 365m by 320m for an area measurement of 116,800m².The ft-ir spectrum showed similar absorption characteristics to purified zein like material.The complaint is confirmed.Photos provided appeared consistent with lab findings.H10.Updated h6.Root cause cannot be determined at this time.H11.Updated h3.

• 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
• MDR Report Key: 10409670
• MDR Text Key: 208016610
• Report Number: 3008500478-2020-00203
• 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
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020

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 Expiration Date: 01/07/2023
• Device Model Number: EZS21TA
• Device Catalogue Number: EZS21TA
• Device Lot Number: 259444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 10/22/2020
• Supplement Dates FDA Received: 09/20/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1