Medical device manufacturer, Biosense Webster, has issued a medical device safety alert concerning its CARTOSOUND Module of the CARTO 3 EP Navigation System, [Catalogue Number: C3SOUND] when used with the SOUNDSTAR eco 8F and eco 10F Diagnostic Ultrasound Catheter, [Catalogue Number: 10439236, 10439072, 10439011 & 10438577].
The manufacturer has received one complaint of image disappearance from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting. This occurred while the patient was experiencing pericardial effusion.
Based on medical evaluation of the health risk profile, the manufacturer believes that the likelihood of harm to the patient is generally low if the ultrasound imaging is not available. However, if the intra-cardiac ultrasound is used to actively monitor an ongoing effusion, the lack of imaging may present a safety issue due to the delay in procuring the resources/equipment to use another imaging modality.
The manufacturer will be updating the product labeling to include and further reinforce the above-mentioned precautionary safety information.
According to the local supplier, the affected product [CARTOSOUND Module for the CARTRO 3 EP Navigation System] is distributed to hospitals in Hong Kong for demonstration purposes. However, SOUNDSTAR eco 8F and eco 10F catheter are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 October 2015