Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its AMS 700 with MS (Momentary Squeeze) Pump. The details of the affected products are identified as follows:
The manufacturer is voluntarily implementing a product removal of unused inventory of the AMS 700 MS Pump following an increase in complaints related to the initial activation of the device. An "initial activation" complaint refers to a problem encountered during the initial activation of the device, typically within the first 2 months after an AMS 700 implant procedure, in which the patient and/or physician is unable or has difficulty activating the pump in order to achieve cylinder inflation, even after exhaustive troubleshooting and patient training.
According to the manufacturer, its internal investigation into an increasing rate of complaints observed in 2020 has estimated up to 2% of all MS Pumps are affected and at risk for initial activation issues. The root cause has been attributed to one mold cavity used in the production of the silicone MS Pump valve block component. Not all pumps manufactured through this cavity are susceptible to an initial activation failure, but a higher rate of complaints has been observed for pumps manufactured through this mold cavity.
The majority of pumps within the scope of the removal (> 98%) should exhibit normal performance with respect to initial activation. However, as the specific mold cavity cannot be determined based on MS Pump finished device serial number alone, the manufacturer decided to broadly scope this voluntary product removal to capture all potentially impacted products.
All MS Pump valve blocks manufactured through this mold cavity are within dimensional specifications. However, minor dimensional differences in components manufactured through this cavity, combined with normal manufacturing variation and patient-related factors (including but not limited to dexterity, obesity, and anatomy), create the potential for an interference fit within the pump and could contribute to difficulty or inability to activate the implanted pump. The most common and most severe health consequence that could result from the described pump failure would be a pump replacement procedure and the normal risks associated with anesthesia and surgery.
The users are recommended to identify their inventory, immediately discontinue use, segregate the affected products and return to the manufacturer.
For recommendations regarding previously implanted devices, the manufacturer recognizes that MS Pump inflation issues can occur throughout the lifetime of a device for a variety of reasons and it may be difficult to distinguish this problem from other pump inflation issues. The cause of initial activation failures associated with this removal is present in the device at the time of manufacture.
If a pump is found to activate and function properly during the initial post-operative patient interactions the pump is not impacted by the problem described in this safety alert. If a pump is found not to operate as expected during the initial post-operative activations, particularly when attempted by the physician using standard troubleshooting techniques, the patient may have a device that is affected by this issue. Note that with any newly implanted AMS 700 device, patient education and training and physician troubleshooting are considered normal activities during the initial post-operative user interactions. If the patient encounters initial activation issues, the widely accepted troubleshooting steps should be employed.
If physicians suspect a patient has a device that is affected by this issue, it is recommended that they manage the patient as they would in the normal course of clinical practice, but with this notification in mind. There is no need to remove normally functioning devices. The manufacturer's representative is available to evaluate the situation and help to support patient's continued health and safety.
For short-term consignment (Loaner Kit) customer, the manufacturer controls all inventory through the loaner kit model and the records indicate users have no product to return. All impacted product in loaner kits has been placed on an internal hold and all loaner kit inventory currently in circulation is not impacted by the product removal.
According to the local supplier, the affected products are distributed in Hong Kong.
For detailed affected material numbers and serial numbers, users are instructed to search in the following link:
www.bostonscientific.com/lookup
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 28 September 2020