The federal Food and Drug Administration (FDA) issued a safety warning this week about Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter. Both catheters are made by Edwards Lifesciences which separately announced it was recalling those products.
According to the FDA recall announcement, “Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death.”
The company claims they are not aware of any fatalities but did admit an infant suffered serious injuries and had to undergo invasive surgery to retrieve a detached balloon. The catheters subject to the recall are specifically made for use In children.
The model numbers of the two medical devices are 830515F and 830705F. The company says they were distributed in the United States between January 9, 2018, and February 25, 2019.
The catheters are used on pediatric cardiac patients. The devices are supposed to enlarge interatrial openings during procedures to correct congenital cardiac defects.
In recent months, other quality control issues have plagued Edwards Lifesciences.
In February, the company recalled 1,426 Swan-Ganz thermodilution catheters. These devices are used in patients requiring intensive monitoring or undergoing serious surgeries.
According to an FDA announcement, some of the devices were incorrectly made causing false blood pressure , oxygen and blood flow readings during and after surgery. Because these devices were often used during open heart surgery, the FDA designated the recall as a “Class 1”, the most serious and urgent of all recalls.
One year earlier, Edwards Lifescience recalled anchors used in its Cardioband mitral valve repair device. The recall was prompted by reports that the device came loose from surrounding cardiac tissue.
According to the company, “Through the review of recent case reports, we have noted an increased number and rate of Cardioband anchor disengagement events, both during and in the days after mitral implantation. Such anchor disengagements have led, in up to two cases, to Cardioband implant dehiscence requiring intervention.”
Are Edwards Lifesciences Products Safe?
Thus far there have been no reported fatalities although the sheer number of recalls and FDA safety alerts is very disturbing. A prominent medical message board had this to say, “Should there be concern in the field for what seems to be an increased level of recalls? Recently, there’s been multiple Certitude delivery system recalls, Cardioband anchors and now the Swan-Ganz Thermodilution catheters were given a Class I recall over issues with the lumen assembly.
Maybe Irvine should wake up? There’s a problem.”
The recent series of recalls follows another Class 1 recall in 2013. At that time, Edwards Lifesciences recalled a number of its bypass catheters over deformed tips. The FDA said the deformed catheters could have deadly consequences.
The 2013 recall involved the Embol-X Glide Protection System, an access catheter used to capture blood clots and tissue fragments during bypass surgeries.
Heart “Destroyed” by Faulty Edwards Lifesciences Catheter
Lest anyone think that defective catheters and heart devices can’t have serious consequences, this story will convince you otherwise.
Paramjit Singh went into Providence Everett Medical Center (Washington state) in October 2004 for a routine heart bypass surgery. During surgery, an Edwards Lifesciences’ monitor malfunctioned and turned off the monitor’s fail-safe devices. That in turn caused the Swan-Ganz catheter inserted into Singh’s heart to heat up and “destroy” his heart. Those aren’t my words, they are the words of the Washington Court of Appeals in 2009.
After the surgery, doctors were unable to restart Singh’s burned heart. He was kept alive with a mechanical heart device for 11 agonizing weeks while his doctors frantically tried to stabilize him and find a heart for transplant.
Singh received a heart transplant at the University of Washington Medical Center but the drugs or transfusions he received to prevent rejection of his transplanted heart caused him to develop blood cancer. Singh then had to contend with both cancer and the aftermath of a heart transplant.
It gets worse, post the surgery, he suffered anoxic brain damage and later his kidneys began to fail. He will probably need both another heart transplant and kidney transplants but his physical state is such that he may not survive any more surgeries.
Singh sued Edwards Lifescience claiming its heart monitor and catheter system were defective. Believe it or not, the hospital also sued the company.
Edwards admitted its liability for compensatory damages to Singh but claimed the hospital was also negligent. Although Edwards agreed to pay compensatory damages to Singh, Singh claimed it wasn’t enough and demanded punitive damages.
In the resulting trial, jurors heard that Edwards Lifescience knew its heart monitor system was defective as early as 1998, 6 years before Singh’s bypass surgery. The jurors believed that the company knew there was a software glitch that could cause the catheter to overheat.
Apparently in 2000 another Edwards monitor caught fire after overheating. Instead of recalling the monitors, Edwards decided to simply replace the software if a monitor was returned for a repair.
Two years after Singh’s heart was destroyed, Edwards Lifesciences finally admitted the monitor malfunctioned and issued a recall. That was two years too late for Mr. Singh.
The jury returned a verdict in favor of the Singh family for $31,750,000 and an additional $8,350,000 in punitive damages under California law. The jury allocated 99.9 percent of the fault to Edwards and 0.1 percent of the fault to Providence. The jury awarded Providence compensatory damages in the amount of $210,000.
Did Edwards pay? No! They appealed making the Singh family suffer for even longer.
In 2009, the appeals court affirmed the verdict and ordered Edwards Lifesciences to pay.
In the aftermath of the lawsuit, Providence Regional Medical Center took the money it received from its lawsuit against Edwards and created the Singh Family Fund for Patient Safety and Quality. The hospital says it using the money for training, equipment and other programs to improve patient safety.
And Paramjit Singh? He is too weak to run his truck stop and hotel. But he told reporters that he isn’t bitter. “God gave me life, I think — a second chance to life, you know?”
Defective Medical Devices – Getting Compensation for Your Injuries
Each day hundreds of people are injured by defective products. Many of those products are medical devices. Instead of saving lives, these defective products maim or kill.
Under U.S. law, it is often difficult to sue doctors but medical device makers remain responsible for injuries caused by their products. Depending on the state where the injury occurred, the designer, distributor and vendor can also be held responsible.
There are tens of thousands of personal injury lawyers and thousands of medical malpractice lawyers. Few have the experience or financial ability to pursue defective products claims, however.
Makers of medical devices are responsible for both design defects and manufacturing defects. An Edwards Lifesciences catheter with a deformed tip is probably a manufacturing defect whereas as a faulty software program that causes a monitor’s fail – safe system to shut down is probably a design flaw. Does it matter? Not if you suffered injuries.
When it comes to cardiac catheterizations, the surgeon (cardiologist) can also be held responsible if they do not follow the appropriate standard of care. Examples include incidents when physicians do not use sterile instruments, puncture a blood vessel during the catheterization or do not properly administer medications before or after surgery.
Potential damages you can receive include medical bills, future medical needs, lost wages, pain and suffering, reduced earning capacity and out of pocket expenses. In certain cases, companies can be liable for punitive damages although the law on these damages varies from state to state.
Victim of Improper Catheterization?
If you or a loved one were hurt or killed by a defective catheter, heart implant device or monitor, contact us immediately. If possible, make sure the hospital saves the product or device causing the injury. The time to bring defective products cases varies widely state to state. In some states you may have as little as one year. Don’t delay in seeking our help.
We are not afraid of huge pharmaceutical companies and medical device manufacturers. If the cause of your injuries appears to be from a mistake by the doctor or hospital staff, we can help you find the right lawyer to insure that you receive the compensation you deserve.
For more information, visit our dangerous products information page. Ready to see if you have a case? Contact us online, by email or by phone 414-704-6731 (direct). All inquiries protected by the attorney client privilege. We do not charge for consultations. Services available nationwide.