Important Safety Alerts

Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheter. The affected devices are identified as follow:

• Device Description: A) NC TREK RX 4.00 X 8MM BDC; B) NC TREK RX 4.00 X 12MM BDC; C) NC TREK RX 4.00 X 15MM BDC; D) NC TREK RX 4.00 X 20MM BDC; E) NC TREK RX 4.50 X 8MM BDC; F) NC TREK RX 4.50 X 12MM BDC; G) NC TREK RX 4.50 X 15MM BDC; H) NC TREK RX 4.50 X 20MM BDC; I) NC TREK RX 5.00 X 8MM BDC; J) NC TREK RX 5.00 X 12MM BDC; K) NC TREK RX 5.00 X 15MM BDC; L) NC TREK RX 5.00 X 20MM BDC; M) NC Traveler RX 4.0 X 8MM; N) NC Traveler RX 4.0 X 12MM; O) NC Traveler RX 4.0 X 15MM; P) NC Traveler RX 4.5 X 8MM; Q) NC Traveler RX 4.5 X 12MM
• Part Number: A) 1012453-08; B) 1012453-12; C) 1012453-15; D) 1012453-20; E) 1012454-08; F) 1012454-12; G) 1012454-15; H) 1012454-20; I) 1012455-08; J) 1012455-12; K) 1012455-15; L) 1012455-20; M) 1013157-08; N) 1013157-12; O) 1013157-15; P) 1013158-08; Q) 1013158-12

The manufacturer has initiated a field action regarding specific lots of the affected products. This action does not affect patients having successfully undergone cardiac procedures using these devices.

Devices from the identified lots may exhibit difficulty or inability to deflate the balloon due to weaker material proximal to the balloon bond resulting from excess heat exposure during manufacturing. The reported frequency of difficulty or inability to deflate the balloon for the affected population of lots is 0.09%. Potential risks include air embolism, thrombosis, myocardial infarction and additional intervention. There have been no reports of patient death associated with this issue. However, additional intervention such as surgery could lead to post-operative complications which include death.

Affected users should immediately stop using the affected devices and return all unused devices. Product replacement is on-going. The manufacturer has stopped shipping the affected lots.

The manufacturer will implement appropriate corrective actions to ensure product performance and work with affected users to replace returned units with similar devices, pending availability.

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 30 January 2020