Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning certain lots of the IntellaTip Mifi XP Temperature Ablation Catheter. The affected catalogue numbers are PM4500, PM4500K2, PM4500N4, PM4790, PM4790K2 and PM4790N4.
An investigation has found that some of the units manufactured from 14 August 2013 to 16 January 2014 were not manufactured according to specification. Although this issue will typically result in an error code on the Maestro 3000 Cadiac Ablation System, under certain conditions or in the event of an error code override, this manufacturing issue may result in excessive radio frequency energy being delivered to the myocardium. To date, the manufacturer has received five complaints related to this issue and none of these complaints reported injury.
The potential health hazards associated with the delivery of excessive radio frequency energy include myocardial perforation and cardiac tamponade, as well as char formation on the catheter tip, which may result in embolic injury. The manufacturer advises users not to use the affected products and these products should be returned.
According to the local supplier, the affected products were not distributed to Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 May 2014