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

The device was returned to edwards for evaluation.Evaluation is in progress.A supplemental mdr will be submitted once additional information is available.

Event Description

It was reported that a cannula had black residue inside.

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.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 black particles which were coming off from inside the lumen.During this whole time the blood pressure was in the 80s.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 and h6 (type of investigation).This event is related to mfr report number 2015691-2021-02221.

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: 11606783
• MDR Text Key: 243545932
• Report Number: 2015691-2021-02220
• 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: 06/10/2021

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 Model Number: EZC21TA
• Device Lot Number: 266668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• 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; 06/10/2021
• Supplement Dates FDA Received: 04/27/2021; 06/10/2021
• Patient Sequence Number: 1