MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES FEM-FLEX II ARTERIAL AND FEMORAL CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number FEMII018A

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss.The potential for serious injury before or during use is not remote.Product evaluation customer complaint of disconnected connector was confirmed.Device was returned with visible traces of blood.T-connector of the cannula was easily detached from the cannula during evaluation.Indications of what appeared to be bonding material were found on the connector end.Cannula was observed to have a kink along the wire-reinforced section of the cannula body 6" proximal from the tip.As received, dilator was inserted into the cannula and was able to be removed without difficulty.No visual damage or other abnormalities were found to the returned device.Photos attached by complaint handler appeared consistent with lab findings.

Event Description

It was reported that the tubing of a femoral arterial cannula separated from the connector during insertion.Another device was used to complete the case.As reported, the device was used for ecmo initiation.There was no abnormality during device preparation and inspection.

Manufacturer Narrative

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.

• Brand Name: EDWARDS LIFESCIENCES FEM-FLEX II ARTERIAL AND FEMORAL CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12348972
• MDR Text Key: 267501119
• Report Number: 2015691-2021-04774
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K140208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: FEMII018A
• Device Catalogue Number: FEMII018A
• Device Lot Number: 63211875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention