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

Model Number EZC21TA

Device Problem Particulates (1451)

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

Event Date 03/07/2021

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device was returned to edwards for evaluation.Evaluation is in progress.A supplemental mdr will be submitted once additional information is available.This event is related to mfr report number 2015691-2021-02220.

Event Description

It was reported that a cannula had black residual inside of the cannula.There was no patient injury.As reported, during the de airing process, the physician noticed a few black specks on the inside of the cannula.The residue did not come out with back bleed.With a tip of forceps, it came out.Due to concern, the physician changed it.

Event Description

It was reported that a cannula had black residual inside of the cannula.Particulate on the cannula was noticed after insertion while trying to de-air it with blood in it during a mitral valve repair procedure.There was no patient injury.As reported, during the de airing process, the physician noticed a few black specks near the upper third of the inside of the cannula.Initially, the surgeon thought it was on the wall.Per the surgeon, it was almost the wording outside leaking to inside.The residue did not come out with back bleed.With a tip of forceps, it came out.Due to concern, the physician changed it.Per received records, this case involved a 58 year old female undergoing urgent mitral valve repair.Median sternotomy was done and the blood pressure was brought to 80 as the aorta was very close to the sternum.The pericardium was open and epiaortic ultrasound showed clean ascending aorta.Aortic and the bicaval cannulation was done.The systolic blood pressures were 80 at the time of cannulation.At this time the surgeon noticed that there were some black particles inside the aortic cannula.These were coming off and he felt it was better to change the cannula.A non-edwards cannula was used in replacement.

Manufacturer Narrative

H3.Device evaluation: customer complaint of an "black residual inside of the cannula" was unable to be confirmed.Device was returned with visible traces of blood.Returned device was examined by two different lab personnel under 3x magnification; reported loose particulate could not be found in the as received condition.Unknown contamination, which appeared to be blood residue, were found along the inside wire-reinforced area of the cannula and the non-wired section.A sample was sent to chemistry lab for ft-ir analysis.The ft-ir spectrum showed similar absorption characteristics to purified zein like material.H10.Additional manufacturer narrative: updated sections b5, d4-expiration date, h4, and h6 (type of investigation).The device history record 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.

Manufacturer Narrative

Updated section h6 (type of investigation, findings, conclusions).Complaint is confirmed by medical records.However, based on what was returned and evaluated, it cannot be confirmed that the reported particulate was returned or what the source of the reported particulate was.There is no evidence of an edwards/supplier manufacturing defect.Corrective actions are not required.Based on the ftir results, the observed contamination may have been blood as observed visually in product evaluation; it cannot be confirmed that the reported particulate was returned or what the source of the reported particulate was.Given the provided information and testing of the returned device, a definitive root cause cannot be conclusively determined.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: AORTIC PERFUSION CANNULAE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11606785
• MDR Text Key: 245234433
• Report Number: 2015691-2021-02221
• 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: 06/08/2021

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: No Information
• Device Expiration Date: 09/24/2023
• Device Model Number: EZC21TA
• Device Lot Number: 283500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 04/02/2021; 06/08/2021
• Supplement Dates FDA Received: 04/27/2021; 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1