MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FERM-FLEX AND FEM-FLEX II (FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND F; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number FEMII018A

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Udi #: (b)(4).The device has been returned for evaluation; however, the analysis is still in progress.A supplemental report will be submitted accordingly once the product evaluation has been completed.

Event Description

It was reported that a fem-flex ii femoral arterial cannula (femii018a) leaked from a pinhole during use.The location of the pinhole is unknown.No other details were provided.

Manufacturer Narrative

Customer complaint of pinhole cannula leakage was confirmed with assessment.Device was returned with visible traces of blood and examined in the biohazard area of the lab.As received, wire reinforced section of the cannula body was observed to be kinked.A leak test was performed on the cannula and leakage was observed from the cannula body.No other visual damage, contamination, or other abnormalities were found to the device.If device is used during cardiopulmonary bypass (cpb), leaks in devices with high flow, such as arterial or venous cannulae, will most likely require an exchange of the device.This will require a temporary interruption of cpb.Since the patient¿s blood flow is dependent on cpb during this portion of the procedure the risk of injury is not remote.The root cause of this event cannot be determined at this time.The instructions for use (ifu) warns, ¿wire reinforced cannulae should be clamped in the non-reinforced section located at the connector end since clamping of the reinforced section may produce permanent cannula deformation, thereby impeding flow through the cannula and risking puncture or tearing of the cannula." the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: FERM-FLEX AND FEM-FLEX II (FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND F
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9911433
• MDR Text Key: 207056361
• Report Number: 3008500478-2020-00193
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2020

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: 09/18/2022
• Device Model Number: FEMII018A
• Device Catalogue Number: FEMII018A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 05/07/2020; 06/08/2020; 07/23/2020
• Supplement Dates FDA Received: 05/27/2020; 06/08/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1