MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FEMEROL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number VFEM022

Device Problems Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

Kinking implies a focal, reversible narrowing of the lumen which may have many root causes.Significant kinks will be identified prior to use, at which time the cannula can be exchanged for another.Smaller kinks that occur during the procedure may be due to anatomic anomalies and not the device.However, the kinking may result in a cannula exchange that disrupts cardiopulmonary bypass.The device was not returned for evaluation, as the device availability is unknown.The root cause of this event remains indeterminable.If new information becomes available, a supplemental report will be submitted.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.

Event Description

Edwards received notification that a femoral venous cannula was observed to be kinked and leaking during procedure.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated h6 per new information received.

Event Description

Edwards received notification that a femoral venous cannula was kinked and leaking during the procedure.As reported the cannulation was left femoral vein by puncture method.One hour after the ecmo started, the patient was transported to icu, the cannula defect was identified during revision.The cannula was replaced along the guidewire without additional punctures and no return to the operating room was required.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated b5 and h6 per new information received.

• Brand Name: FEMEROL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10741739
• MDR Text Key: 213248974
• Report Number: 3008500478-2020-00211
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• 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: 10/02/2020

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: 05/29/2022
• Device Model Number: VFEM022
• Device Catalogue Number: VFEM022
• Device Lot Number: 62380289
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/12/2020; 12/04/2020
• Supplement Dates FDA Received: 12/03/2020; 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention