Medical device manufacturer, Abbott Vascular, has issued a field safety notice concerning MitraClip Mitral Valve Repair System (product number MSK02ST).
Abbott Vascular has received a total of 4 reports since 2008 where the Actuator Knob of the Clip Delivery System was incorrectly turned in the clockwise direction during Clip deployment. In the event that the Actuator Knob is incorrectly turned, the device may incur damage that prevents the deployment of the clip. Additional medical intervention or conversion to surgery may then be required.
The current inventory of product is acceptable for safe use following the steps highlighted in the Instructions for Use (IFU). Patients that have had Clips successfully implanted are not affected by this action.
The manufacturer advises all users to consult the approved IFU that were distributed with each device, which contains important information for the proper Clip deployment steps. Specifically, step 17.2.2 states: "Turn the Actuator knob of the DC approximately 8 turns counterclockwise. If it is difficult to turn the Actuator Knob, confirm that the Arm Positioner moves freely. Retract the Actuator Knob after it is fully unthreaded." Subsequent to this step, the following Warning appears: "Failure to stop turning the Actuator Knob when resistance is felt or turning the Actuator Knob in the clockwise direction may result in inability to deploy the Clip." Furthermore, the manufacturer will add a directional arrow on the Actuator Knob of newly manufactured devices to aid in proper Clip deployment.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 28 February 2013