Boston Scientific was forced to recall two of its cardiology devices used in the treatment of atherosclerosis following numerous complaints of the devices’ fracturing inside of patients’ bodies and multiple resulting deaths. The FDA has issued a Class I recall of 955 of the devices, which is the sternest and strongest form of recall the FDA can issue. The Chicago medical device liability attorneys of Rosenfeld Injury Lawyers are currently accepting clients who have been injured or lost loved ones during procedures in which the device fractured or perforated major blood vessels within the heart.
Common Uses for Guidewire Devices
Boston Scientific produced and disturbed 955 devices that are marketed as part of its Rotablator Rotational Atherectomy System. These devices are used to treat a condition called atherosclerosis, which is the buildup of plague within the major arteries in the heart that places the patient at grave risk of cardiac arrest or heart failure. The RotaWire Elite and wireClip Torquer guidewire devices use a very small wire to enter and navigate major blood vessels and then to break up and remove plaque with a rapidly rotating burr.
The RotaWire Elite and wireClip Torquer are only two of many guidewire devices sold by Boston Scientific, but the FDA has asserted that the other devices remain safe for use. Its recall of the two devices comes following numerous complaints during the products’ limited market releases. It is important to understand that the other devices associated with this system might still be harmful, even though the FDA has not yet issued a recall. At the moment, there simply is not enough data or evidence for the FDA to take action, except on the two components that have been recalled.
Multiple Deaths Mark the Need for Added Scrutiny
Three complaints were filed during the limited market release of these devices stating that the device fractured while inside the patient. Two of these fractures resulted in the burr migrating into the pericardium, which is the membrane that protects the heart. In the first procedure, a stent was placed to address the perforation, but the patient did not survive and the other patient had a fragment of the device removed surgically.
In yet another documented case, it was recorded that the diamond tipped burr spun at nearly 190,000 rotations per minute at the moment the device fractured inside of the patient. The burr burst a major blood vessel and surgeons were able to remove the burr and wire, but the patient died only four days later. Following this series of unfortunate events, the FDA issued its Class I recall of the devices on November 13, 2015.
A Class I recall is issued when the FDA believes that there is a significant risk that the use of a product will result in serious injury or death. It is reserved only for the products that have the most clearly defined risk of failure or causing severe harm to patients. While the recall only targets two devices, questions are being raised about how safe other guidewire devices are and whether the risks associated with their use are outweighed by the benefits they provide.
Boston Scientific is no stranger to recalls or litigation. It is also the defendant in numerous lawsuits filed over defective transvaginal mesh products that the company has refused to pull from the market despite numerous reports of complications and device failures. Cases linked to the Rotablator Rotational Atherectomy System have the potential to develop into a large class action lawsuit as more patients come forward with complaints.
Lawsuits Filed by Injured Patients
Patients who suffered perforations of major blood vessels or the migration of a fractured guidewire device and those who have lost loved ones due to these complications are bringing lawsuits against Boston Scientific for the cost of the medical treatment required to repair damaged blood vessels and the pain and suffering caused to bereaved families. Since the RotaWire Elite and wireClip Torquer are only two devices used in conjunction with the Rotablator Rotational Atherectomy System, it may be possible that other associated devices have harmed other individuals.
Whenever a device manufacturer produces a product that causes bodily harm or death, victims have the right to receive compensation, even if the device was used as it was intended. If you believe that you were injured by a defective guidewire device, our Chicago medical device negligence lawyers would like to investigate your claim to determine whether it is in your best interest to file a lawsuit.
Rosenfeld Injury Lawyers is a leading provider of award winning legal services in the Chicago area and has a team of dedicated medical device attorneys working on these cases who have experience and success with similar cases in the past. Our knowledge and experience allow us to give you the best possible chance of recovering the compensation to which you are entitled.
Contact us today to arrange a free consultation with one of our highly qualified Chicago medical device liability attorneys so that we can gather all of the information we need to get to work on your behalf. If you are unable to travel to one of our offices, we are happy to come to you and will review all of your legal options with you so that you know what you can expect and how likely your case is to succeed. Our services are offered risk free and our lawyers work on a contingency basis— meaning we only get paid if we are able to secure damages on your behalf.