Fragments of a Device for Minimally Invasive Procedures Left in Patients’ Bodies
By Paul da Costa on December 22, 2015
Boston Scientific Corporation issued yet another emergency recall on one of its products. The device, called a Chariot sheath, has only been on the market since the FDA approved it in June. It is typically used to perform minimally invasive procedures on patients’ arms or legs.
The device is a “guiding sheath,” since it is inserted into the blood vessels so that thinner tools can slide through it and reach the sites of disease. After 14 reports of “shaft separation,” Boston Scientific voluntarily issued a Class 1 recall, which means that the device can cause serious medical complications or death.
Worldwide, 7,000 Chariot sheaths have been sold. Boston Scientific advised doctors last month that they should immediately stop using the devices and check on the patients on whom the sheaths have been used. Parts of the device have broken off in certain patients, obstructing blood flow.
In four of the 14 shaft separations, the device broke inside the patients’ bodies. The break was visibly noticeable in these four cases. It is not always evident, however, when the sheath breaks. It is very possible, therefore, that other patients may have device fragments inside of their bodies too.
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