Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its EndoVive One Step Button, EndoVive Button Decompression Tube and EndoVive Low Profile Replacement Button.
The manufacturer has become aware that specific lots of the affected products may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the percutaneous endoscopic gastrostomy (PEG) Button.
A user attempting to insert the decompression tube adapter will feel increased resistance when the protrusion contacts the button, and the user may then decide to pull out the decompression tube adapter, leading to delay of decompression. If the user applies additional force to fully insert the decompression tube adapter, it could dislodge the button into the stomach. If the decompression tube adapter is successfully inserted, then the increased resistance during removal could lead to pulling the entire EndoVive Button out of the body, which would require surgical re-insertion. There is a remote possibility that manipulating the decompression tube adapter with the protrusion could lead to a tear or perforation of the button tube, which would allow for exposure to the peritoneal cavity which could then lead to infection (peritonitis).
Users are advised to immediately discontinue use of and segregate recalled product.
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 17 September 2015