A component of Boston Scientific Corp.’s Rotablator Rotatioal Atherotomy System has been recalled due to the possibility of cracking and separation of components. The component recalled is generally known as the RotaWire “Elite” core wire and is being recalled due to risk of serious injury and death.
A “Medical Urgent Medical Device Recall Removal – Immediate Action” letter was issued by Boston Scientific starting October 9, 2015 advising that distribution and use of the recalled device was to be immediately stopped, according to the U.S. Food and Drug Administration (FDA).
The Rotablator Rotational Atherectomy System is used during atherectomy, a procedure that involves opening narrowed arteries to improve blood flow. The components involved include the Rotawire Elite Guidewire and wireClip Torquer Guidewire. The RotaWire “Elite” core wire defect may cause tamponade, which is a decrease in heart function due to blood accumulating in the sac surrounding the heart; movement of wire fragments in other parts of the body; and myocardial infarction (heart attack).
To date, there have been three reports of injury; one patient died as a result of an emergency procedure to remove a broken wire, according to the FDA. Intentional occluding (blocking off) of, or placing stents into, the affected artery, in addition to emergency heart surgery have been used to correct the RotaWire Elite core wire defect.
from Parker Waichman http://www.yourlawyer.com/blog/boston-scientifics-rotablator-system-may-be-associated-with-serious-injuries/
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