Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Maestro 4000 Cardiac Ablation System Optional Footswitch accessory [UPNs: M00440000, M0044000D0, M0044000H0, M0044000R0 & M0044000Z0].
The manufacturer has received reports of unintended continuation of radiofrequency (RF) energy delivery from the Maestro 4000 Cardiac Ablation System after the foot switch has been released.
Continuing display of RF delivery parameters and emission of audible tone after foot switch release is indications of unintended RF delivery and may result in life-threatening harm. There was one reported case of conductive pathway injury (heart block) during RF energy delivery which may be associated with this behaviour.
According to the manufacturer, it has confirmed the Maestro 4000 is meeting performance expectations and that this rare behaviour can be resolved with existing instructions within the operator's manual.
If RF energy delivery continues after releasing the foot switch, the affected users should follow the instructions to stop RF energy delivery by pressing the RF Power Control button on the Generator or Remote panel.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 25 June 2018