Medical device manufacturer, Medtronic Ltd., has issued a field safety notice concerning Symplicity Catheters. The affected model numbers are IDERDN006 and RDN006.
The manufacturer has observed a connection issue complaint rate of approximately 5% of devices provided since enrollment of the Symplicity HTN3 trial began. These connection issues cause unstable temperature readings or lack of signal to the generator. In events where a connection failure leads to unstable temperature reading, the generator's safety algorithm is triggered and energy delivery is terminated, or if there is a lack of signal to the generator, it will not initiate treatment, thus in either situation protecting the patient from unsafe treatment.
These connection issues manifest in one of the following ways:
The result of these connection failures is the potential need during the procedure to replace the catheter to successfully complete the renal denervation procedure.
The manufacturer advises users to connect the catheter into the generator prior to inserting into the patient according to the IFU. Furthermore, the manufacturer advises users that if observing any of the conditions above, they should follow the steps below:
Medtronic has also developed a new catheter connector.
According to the local supplier, Medtronic International Limited, the affected devices were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 28 January 2013