WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) characterized Boston Scientific’s Angiographic Catheter Imager II 5F (Imager) as a Class I recall initiative. The FDA’s Class I designation means that the FDA believes that the defect in Boston Scientifics’ Imager could kill or cause a serious injury to a patient. In its recall alert published recently, the FDA reported that the catheter tip from the Imager could detach from the device while in use during an otherwise normal procedure. According to MedTechDive.com, the Imager caused nine injuries so far. The FDA expressed concern that a patient might suffer a life-threatening medical event such as obstruction of blood flow or an embolism.
Boston Scientific designed the Imager to deliver contrast agents to a patient’s carotid artery, among other vascular structures. The tip of the Imager, which is the reason for the recall, is soft. The softness and flexibility of the tip reduce the risk of traumatic injury to the patient. Notwithstanding Boston Scientific’s soft tip design, the company reported that it received numerous complaints from physicians stating that the tip of the device was breaking. Boston Scientific said it narrowed down the defective tips to a few lots. As a result of its investigation, Boston Scientific recalled twelve (12) lots comprising of 6,130 individual devices.
Since the Imager is inserted into a patient’s arteries or veins, there is a tremendous risk of a broken tip becoming lodged in the bloodstream. The fractured tip could lodge in the lungs, heart, or brain and kill the patient by causing an embolism or stroke. Additionally, the patient could sustain significant injuries from the surgeon trying to remove the broken piece of machinery. The patient has no options if the tip of the Imager breaks while in use. A surgeon must remove the foreign material.
To date, Boston Scientific has not determined why the Imager’s tips as susceptible to breaking.
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