Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Entrada Needle (Accessory Infinion CX lead). The affected devices are identified as the following: -
The manufacturer has detected some products did not meet the acceptance criteria during a needle resistance loss leakage test in the accelerated 2 years aging test which was performed for an additional manufacturing site. Therefore, the manufacturer is initiating voluntary removal of the products in Japanese market.
According to the manufacturer, if there is leakage of the products, the operator may not be able to feel sufficient resistance. This could potentially result in prolonged procedure and may puncture the spinal cord beyond the epidural space as severe health impact. However, as it is recommended that this procedure to be performed under X-ray fluoroscopy in the instruction, a severe health impact would not occur. While the product is currently being sold worldwide, there have been no complaints related to this event.
The users are recommended to return unused removal products and not to use the affected products.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 April 2018