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 Problem Fluid/Blood Leak (1250)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 12/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to edwards for evaluation; however, a photo of the device was received and evaluated.The image showed a cannula at the connector end with a tie bond.Report of leakage on cannula was confirmed through image evaluation.The cannula appears to have a leakage at the proximal connector end.A supplemental mdr will be submitted as new information becomes available.These cannulae are used to divert large volumes of blood from the heart to the cardiopulmonary bypass machine during cardiac surgery procedures.If not detected prior to use, the bypass machine may alarm for decreased flow.A partial or complete separation will require exchange of the cannula, temporary interruption of bypass, and in a worst case scenario retrieval of the device fragment.Depending on the location of the fracture/separation, it may also result in significant blood loss.In this case, the hcp placed a tie bond around the cannula to prevent blood loss and/or an exchange of the cannula during ecmo.The cause of the event cannot be determined at this time.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.

Event Description

Edwards received notification that blood leakage was seen at cannula connector during vv ecmo.As reported, the leakage was observed at the proximal part of cannula connector with ecmo tubing after few minutes of cannulation.The cannula was used for 15-20mins when the leakage started and the blood lose was 10-15ml of blood volume.No additional intervention was needed because of this blood leakage, only the connector part of cannula was fixed with tie bond.Ecmo therapy was not interrupted.As reported, it was an off-label use.The cannula was used to cannulate right intra jugular vein during vv ecmo and it was used a 3/8 maquet pls circuit with the connector.Patient expired due to other reason, not related to cannulation.

Manufacturer Narrative

Updated section h6.Manufacturing, design, supplier, ifu, and labeling defects were not confirmed.Trend is out of control.Fmea line item is appropriate.Capa and pra action are not required.The root cause cannot be determined at this time.

• 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: 11220006
• MDR Text Key: 238917160
• Report Number: 3008500478-2021-00218
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

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: 03/31/2023
• Device Model Number: FEMII018A
• Device Catalogue Number: FEMII018A
• Device Lot Number: 63094207
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/23/2021
• Supplement Dates Manufacturer Received: 01/30/2021; 02/23/2021
• Supplement Dates FDA Received: 02/11/2021; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR