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

Model Number EZC24TA

Device Problems Break (1069); Fracture (1260)

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

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The evaluation has not been completed at this time.A supplemental report will be submitted.

Event Description

It was reported that the connecting end of the aortic perfusion cannulae had a small chip while cannulating.No loose pieces were noted.The cannula continued to be used during the case and worked properly.As reported, this was a procedure of endovascular harvest greater saphenous vein, reverse cabg x 3.This was a (b)(6) yrs-old female patient with a history of coronary heart disease and diabetes.

Manufacturer Narrative

Device was returned with visible traces of blood and examined in the biohazard area of the lab.As received, the connector end of the cannula was found chipped.Chipped piece was not returned with device.No other visible damage, contamination, or other abnormalities were observed.Per the product evaluation, the customer report that the "cannula had a small chip" was confirmed.Per the engineering evaluation, a manufacturing, supplier, design, ifu, and labeling defect was not confirmed.The aortic cannula connectors are visually inspected for cracks during receipt and connector bonding, as well as during packaging of the device.Additionally, the device was returned in a used condition; therefore, damage due to clinician use cannot be ruled out.A definitive root cause could not be identified.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

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: AORTIC PERFUSION CANNULAE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8303312
• MDR Text Key: 135179359
• Report Number: 3008500478-2019-00104
• 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
• Report Date: 01/10/2019

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 Expiration Date: 07/01/2021
• Device Model Number: EZC24TA
• Device Catalogue Number: EZC24TA
• Device Lot Number: 61438663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 03/26/2019; 07/23/2020
• Supplement Dates FDA Received: 04/11/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 79