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FDA MedWatch – Reporting Serious Problems

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FDA MedWatch – Reporting Serious Problems


Medical products from assistive devices to medications and dietary supplements all have one thing in common – they can cause serious problems for a patient. This is one reason for the establishment of MedWatch –  a reporting branch of the FDA. 

When a patient notices that something is not working as it should, MedWatch gives them a venue to let the FDA know. So, in a way, along with treating physicians, patients are on the front lines and a valuable source for potentially dangerous situations. 

Dragonfly Opstar™ Imaging Catheter

Recently, a product made by Abbott was recalled due to its ability to cause a significant and potentially fatal medical issue. The product is called the Dragonfly Opstar™ Imaging Catheter, which is used for intravascular imaging using optical coherence tomography, utilized for medical procedures. Usually, it is used to travel through tortuous paths within the body and produce clear and detailed images.

Improvements With the Dragonfly Opstar™ Imaging Catheter

The catheter was improved over older issues by:

  • The shaft of the catheter was redesigned so pushing it through intravascular structures was easier
  • Reinforced guidewire
  • Tapered three-layer guidewire tip 
  • Lens was redesigned to make the image 44 percent brighter
  • The proximal marker was at a greater distance from the lens to make pulling back easier
How Is the Dragonfly Catheter Used?

The Dragonfly catheter is used to image coronary arteries and is favored in those who may require transluminal interventional procedures, one within the artery itself.

Are There Times the Dragonfly Catheter Is Prohibited?

If the use of the dragonfly catheter might interfere with the person’s health status, its use is contraindicated. Some examples of this are:

  • Failed kidneys
  • Large clots
  • The presence of sepsis and bacteremia (where the blood is infected)
  • If the patient had a coronary spasm
  • A coagulation system problem
  • If the patient has a total occlusion
  • If CABG surgery is contraindicated
  • If the patient is in shock
  • If the patient cannot receive systemic anticoagulation
Adverse Reactions

Prior to the recall, the following adverse reactions were listed:

  • Unstable angina
  • Bleeding
  • Artery injury or perforation
  • Abnormal heart beats
  • Spasm of the coronary artery
  • Formation of occluding clot
  • Heart attack
  • Embolism
  • Kidney issues
  • Revascularization
  • Fatal outcome
  • Tissue death
  • Inflammation 
  • Granuloma
Recall of Opstar™ Imaging Catheter

So, what happened to initiate a recall of the catheters? The marker band the further away from the tip of the catheter became loose, and in several instances, it separated from the unit during a procedure. This poses a problem, since the marker band may stay in the body after the catheter has been removed. This can cause a vascular injury such as an embolism where the blood vessel is blocked by a blood clot. Other problems could be a tear in the blood vessel, heart attack, reduced blood supply to the heart, infection or death.

Incidence of Problems

Reports show that the marker band did separate from the catheter in two cases out of five. In one case, the patient was injured. However, at the time of the recall, no deaths were reported due to the loss of the catheter marker band. 

Recall Instructions to Practitioners

Specific lots have already been recalled. Abbott sent the following message along with the recall and asked that:

  • Practitioners stop using the catheter
  • Return unused catheters to the manufacturer
  • Notify anyone who underwent a procedure with the catheter
  • Report additional adverse effects with the catheter
Production of Defective Products

No one can guarantee that all products are perfectly made. That is why so many methods are put into play to remove damaged devices and medications from the market. Of course, doing this requires full participation from the manufacturer. When that does not happen, the incidence of serious issues increases, hurting many people. 

Can a Defective Product Be Part of a Lawsuit?

Of course, it can. When a manufacturer fails to produce a safe product and someone is injured by it, the plaintiff has the right to file a claim against the manufacturer. California clearly recognizes the responsibility held by the manufacturer and instituted the law of strict liability.

Under this law, the plaintiff (injured party) does not have to prove negligence, a costly and time-consuming endeavor. Instead, they need to show that the product was used as intended without alteration. It is important to retain a law firm with experience in product liability cases and the resources necessary to bring the case to a successful conclusion.

How We Try to Help Current Clients and Future Ones

At AutoAccident.com, we make every effort to help clients hurt by a faulty product and those who may be hurt in the future. To this end, we have established a site that will list defective products whether recalled or about to be taken off the marketplace. We will keep a constant watch on MedWatch and other respected, informational sites every day to bring this information to you. If you are using a defective medical product or did so, it is best to talk to your doctor. If your doctor does not want to fill out the form provided by the FDA, we will be glad to do it with you. In this way, subsequent people will not be at risk of being injured. 

The form can be found at the MedWatch site. It is called Consumer Reporting Form FDA 3500. You can also contact the FDA by calling (800) FDA-1088. You will be able to learn more about reporting by reading the following page

It is not always easy to choose the best lawyer for your case. Attorney Ed Smith presents the following video to help you when looking for legal assistance:

Sacramento Defective Medical Device Lawyer

I am Ed Smith, and I am a Sacramento defective medical device lawyer. If you or a member of your family needs to report serious problems after using or being treated with a product, call us for our free and friendly help at (916) 921-6400 or (800) 404-5400 to schedule a no-charge case review. You can also reach out to us online. We will sit down with you and answer your questions and help you in this matter.  

In the event that someone in your family or you were injured by a manufactured product, we will assist in filing a product liability lawsuit against the manufacturer. Don’t let companies take advantage of your well-being. You have the right to be compensated and not pay both physically and mentally for another’s wrongdoing. 

Photo attribution: Image by Sasin Tipchai from Pixabay

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