Boston Scientific has issued a medical device safety alert concerning its ROTAPRO Rotational Atherectomy System.
The manufacturer is initiating a voluntary removal due to a testing non-conformity during the manufacturing process of the pneumatic kit component of the system. As a result, the performance of the pneumatic kit may cause unpredictable changes in burr speed.
According to the manufacturer, the most serious injury that is expected to occur is the burr becoming stuck in the lesion or vessel trauma, which may result in the need for additional percutaneous intervention. Other adverse health consequence includes burr catheter withdrawal and exchange for a similar device. The manufacturer advises users to immediately discontinue use of and segregate affected product.
According to the local supplier, the affected products are NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Nov 2021