Medical device manufacturer, Biosense Webster, has issued a medical device safety alert concerning its PENTARAY Catheters. This involves all lots of PENTARAY Catheters with catalogue numbers D128201, D128202, D128203, D128204, D128205, D128206, D128207, 0128208, D128209, D128210, D128211, and D128212.
PENTARAY Catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
The manufacturer is updating the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves. The current language in the IFU provides a precaution against use of the PENTARAY Catheter in patients with prosthetic valves under the contraindication section stating: "[The] use of this catheter may not be appropriate for use in patients with prosthetic valves." The manufacturer is updating the contraindication statement as follows: "Do not use PENTARAY Catheters in patients with prosthetic valves".
According to the manufacturer's medical assessment, there is a high risk of catheter spline entanglement when using PENTARAY Catheters in patients with prosthetic valves. If excessive force is applied on the entangled catheter spline, there is a potential for parts to detach and embolize inside the patient's body, which may lead to serious complications like stroke, transient ischemic attack, myocardial infarction or pulmonary embolism. The likelihood of these serious complications remains low.
The manufacturer advises users that they may continue to use PENTARAY Catheters in accordance with the updated contraindication.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 April 2016