A voluntary recall has been issued for the Chariot™ Guiding Sheath after more than a dozen reports of shaft separation. Several patients needed additional medical procedures to retrieve pieces that broke off inside their body during surgery.
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Boston Scientific Corp. manufactures the Chariot Guiding Sheath, a device used for minimally-invasive procedures in the legs and arms. It is called a “guiding sheath” because it is inserted into a patient’s blood vessels so that smaller tools can slide inside. It has only been on the market since June 2015 and is based on a device that was approved in 2009.
FDA Issues Class I Recall
In November 2015, Boston Scientific issued a Class I recall for about 7,000 Chariot Guiding Sheaths due to problems that could lead to severe injury or death.
The company received 14 reports of “shaft separation.” In four cases, the separation occurred inside the patient’s body. None of the incidents resulted in severe injuries, but additional surgery may be necessary to retrieve broken pieces of the device.
Broken pieces of the shaft could potentially travel in the bloodstream (called an “embolism”) and cause life-threatening complications. According to the FDA:
“The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs.”
Boston Scientific asks doctors to contact patients who had procedures involving the Chariot Guiding Sheath to check on their well-being. Device shaft separation and embolized fragments may not have been recognized at the time of the procedure.
Adverse Event Reports
Many of the adverse events describe shaft separation when pulling the Chariot Guiding Sheath out of a patient. For example, one report from October 12 states that “the Chariot sheath broke in half leaving half still inside the patient as they were pulling it out.”
According to another report filed with the FDA in September 2015:
“While removing the sheath, the sheath broke near the top and remained inside the patient. … The surgeon then made a small incision and was able to fish out the remaining portion of the Chariot Guiding Sheath. No patient complications were reported and the patient’s status is fine.”
Side Effects & Complications
- Shaft fracture or separation
- Embolization of fragments
- Obstruction of blood flow
- Additional surgery
- Kidney damage
- Intestinal damage
- Limb damage
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