Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its AngioJet Ultra 5000A Console Foot Switch.
The manufacturer has received field reports regarding the AngioJet Ultra 5000A Console foot switch sticking during use resulting in an undesired continued operation of the device. If this situation occurs, perform the troubleshooting steps per the operator's manual. An attempt can be made to manually release the footswitch, or turn the console off to deactivate the catheter.
According to the manufacturer, there have been no reported patient adverse events as a result of these complaints. The complaint review shows that this issue results in a prolongation of the procedure in order to perform troubleshooting steps and remove the catheter. The most serious consequence from this issue could be the need to abort a procedure if the situation has not been resolved and alternative options are not available.
If affected users noticed this issue with AngioJet Ultra 5000A Console Foot Switch at their facility, they should discontinue use and contact the local sales representative. If the foot switch is operating correctly, no action is necessary.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 08 February 2017