Abbott Vascular has issued a medical device safety alert concerning its NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter.
The manufacturer has initiated a voluntary field action regarding specific lots of the NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. Product from the lots may exhibit difficulty in removing the protective balloon sheath. If excessive force is required to remove the balloon sheath, the sheath may damage the device causing problem with inflating and deflating the balloon.
According to the manufacturer, the worldwide frequency of tight sheath removal, inflation and deflation reported events are 0.12%. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, leading to multiple post-operative complications and death. This action does not affect patients having successfully undergone cardiac procedures using these devices.
The affected users are advised to take the following actions:
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 22 March 2017