Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning Encore 26 Advantage Kit [Catalogue no.: 04527-01, 04527-05]
The manufacturer has discovered that users of the Encore 26 Advantage Kits which were manufactured between 3 Aug 2012 and 18 Sep 2012 may experience difficulty in passing guidewires through the insertion tool which is included with Encore 26 Advantage Kits. The difficulty to pass guidewires, especially J-tipped guidewires, through the insertion tool is caused by a lack of smoothness within the hub/hypo tube transition in some devices. This issue may lead to a clinically insignificant prolongation of the procedure upon attempt to insert a guidewire into the insertion tool but it not expected to cause increased risk of injury.
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 17 October 2012