SUPER TORQUE® MB Angiographic Catheter 의 안전성 경고

Safety alert

2011-11-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20111129a.html

Field safety notice: cordis super torque® mb angiographic catheter medical device manufacturer, cordis, has issued a field safety notice related to a specific subgroup of cordis angiographic catheters, super torque® mb angiographic catheter. manipulation of the super torque® mb angiographic catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter. stretching or elongation of the super torque® mb angiographic catheter during endovascular procedures could result in the marker bands moving along the catheter. in extreme cases, marker bands may come off the super torque® mb angiographic catheter and dislodge into the vascular system. movement of the marker bands can result in inaccurate reference and device sizing. dislodgement of the marker bands into the vascular system can result in additional intervention, embolism, thrombosis, or other vascular complications. the manufacturer is in the process of updating the product labeling. according to local supplier, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.