Bard PowerPort Catheter
The Bard PowerPort, also known as the BardPort, is an implantable catheter device used for intravenous delivery of fluids or medicine. Manufactured by Bard Access Systems Inc., a subsidiary of Becton, Dickinson and Company, the device is about the size of a quarter. Its structure consists of two main elements: an injection port and a polyurethane catheter. The injection port, characterized by a raised center or “septum,” is where the needle is inserted to deliver medication. From here, the medication travels through a flexible tube -- the catheter-- and enters the bloodstream. The PowerPort is used on patients who require repeated and prolonged access to the vascular system for IV administration of fluids or medication, such as chemotherapy.
A defect in the PowerPort stems from the Chronoflex polyurethane material that makes up the flexible catheter tubing component. Experts have discovered that chemical design flaws of the tubing could make it more likely to fracture or have pieces break off and migrate out of position. This can cause severe injuries, including internal vascular damage.
The catheter contains a mixture of polyurethane and barium sulfate, which increases its visibility in radiologic studies. “We have cases where the polymer from the port line has been exhibiting problems because it is unstable,” says attorney Dickey. “Mostly we are seeing infection and fractures where the port and catheter detach and wiggle around in the body.”
According to one lawsuit filed by Dickey:
“The catheter involved too high a concentration of barium sulfate particles, leading to improperly high viscosity of the raw silicone or polyurethane before polymerization and causing improper mixing of barium sulfate particles within the polymer matrix…this improper mixing forms pockets of barium sulfate and entrapped air throughout the catheter body and surface, which weakens the catheter’s mechanical integrity and creates a rough catheter surface.”
In other words, the barium sulfate particles dissociate from the catheter’s surface over time, resulting in microfractures and other structural alterations that compromise the mechanical properties of the catheter. “When these particles fall out an irregular surface or “hidey hole” is created and if that is infected it’s hard to get rid of – it finds a home where antibiotics won’t find it,” says Dickey. “Also, when you have imperfections from polymer not holding an additive, say by your shoulder, movement by the body creates a physical stress on polymer. In worst case scenarios – and we have seen significant amounts of cases—pieces of polymer fracture and migrate elsewhere. A piece could land anywhere that your vascular system pushes it to, such as getting stuck in your heart. Then you have to fish it out again, which requires surgery.”
Bard PowerPort Lawsuit
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- fracturing and migrating
- precipitating thromboembolism
- precipitating infection
“To fix this defect, all Bard has to do is put an extra coating on the outside of the device and make everyone safer,” says Dickey, “but every time you retool a device there is a cost. As well, its approval by the FDA is based on the 510(k) process. If Bard keeps changing the product the FDA could say it is different for the original device, which would trigger the FDA to review it. Any delay or stumble will cause Bard to lose its dominant market share.”