Flextome Cutting Balloon Device Recall
Boston Scientific Corp. said it was voluntarily recalling all 40,000 of its Flextome Cutting Balloon systems because of a malfunction that could require additional surgery.
The Company is initiating this recall because it has determined through complaints and testing that the distal shaft of the catheter may separate during withdrawal of the device, which may prolong the procedure or require additional surgery.
A defect of this type could also cause serious injury or death. A total of eight complaints involving patients have been received by the Company, of which three required surgery.
The recall involves only the Flextome cutting balloon delivery system and the Peripheral cutting balloon microsurgical dilatation system. The products were distributed to hospitals worldwide and the company is notifying affected facilities.
About the Flextome Device
The Flextome cutting balloon device was created by Boston Scientific Corporation. It is a nylon balloon material designed to treat more complex lesions. It consists of 3 or 4 microsurgical blades on its outer surface lined lengthwise, a difference from most other angioplasty devices. When inflated, these blades on the balloon scrape away at the plaque build up in the coronary arteries.
What is Angioplasty?
In 2002 in the United States, 1,204,000 angioplasties were done. Of these 657,000 were percutaneous transluminal coronary angioplasties (PTCAs). The number of men who has the procedure done was 802,000 and the number of women was 402,000.
Angioplasty is an invasive medical procedure performed to reduce or eliminate blockages in coronary arteries in which a balloon is used to open narrowed or blocked blood vessels of the heart. Once properly positioned in the artery, the balloon is inflated for approximately 2 minutes to press open the blockage and create a channel that increases blood flow through the artery. The goal is to restore blood flow to blood-deprived heart tissue. The blockage is fat and cholesterol that can accumulate on the inside of arteries and form deposits called plaque. This disease process is called atherosclerosis. The coronary arteries that supply blood to the heart itself can be narrowed or blocked by this accumulation.
Symptoms of blocked arteries may include:
- chest discomfort
- shortness of breath
- fatigue
Blocked arteries are the number one cause of coronary artery disease (CAD) and can lead to a heart attack. This year, an estimated 1.1 million Americans will have new or recurrent heart attacks, and for more than 45% of these people the attacks will be fatal.
Even after treatment such as angioplasty it is possible for arteries to re-narrow or become blocked at the same site where treatment has already taken place. This is called restenosis.