Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its lceFORCE, lcePearl, lceRod, lceSphere, lceSeed, lceEDGE Cryoablation Needles and Prostate Cryoablation Kits. (Details of affected products can be referred to the manufacturer's field safety notice)
Boston Scientific is voluntarily issuing a product advisory for the lceFORCE, lcePearl, lceRod, lceSphere, lceSeed, lceEDGE Cryoablation Needles and Prostate Cryoablation Kits on behalf of GaliI Medical Ltd., the legal manufacturer of the products. The advisory is meant to provide educational guidance on proper testing of the needles prior to use. The advisory is being communicated in response to recent complaints of gas leaks from the needle shaft that determined some users of these devices are not adhering to the preparation technique described within the products' Instructions for Use (IFU), which ensures needle integrity of the entire needle shaft. The advisory is intended to reinforce existing instructions within the IFU directing users to fully submerge the entire needle shaft in sterile water or saline prior to the patient being anesthetized to identify a possible defective needle, therefore reducing the likelihood of patient harm from a gas shaft leak during the procedure.
If testing is properly performed prior to use, a gas leak can be detected and the device can be exchanged prior to patient exposure with no adverse health consequences. The most serious potential injury would be due to incomplete integrity and functionality testing creating the risk of gas entry inside the body with the potential of life-threatening gas embolism. While the most severe outcome has not been reported, there have been two complaints of patient harm that required medical intervention to remove gas from chest cavities.
According to the manufacturer, when the device is prepared and tested as per instructions in the IFU, a shaft leak would be clearly identifiable to the user and the device would be exchanged for another. No product is being recalled and users are not required to return product to the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 24 November 2020