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The Penumbra JET 7 Xtra Flex catheter often has been used in thrombectomy procedures where surgeons remove blood clots from the arteries in the brain following a stroke. It has been discovered that the device may do more harm than good.
Although the device has only been on the market since mid-2019, the FDA MAUDE database has already received approximately 18 reports of fatalities associated with the device. In many of these reports, the tip of the catheter reportedly broke in surgery, causing complications such as vessel ruptures and eventual patient death. This safety issue has gained the attention of medical professionals, attorneys, and others.
What Is a Catheter?
A catheter is a thin tube that is inserted into the body for a number of purposes. There are countless catheters available for specialized purposes, with the most common being the urinary catheter used to drain urine from the bladder post-surgery and during other situations.
Catheters may also be used to drain fluid collections, measure blood pressure and intracranial pressure, administer medication through an IV, and more.
What Is the Penumbra Catheter?
According to Penumbra, Inc.’s website, the Penumbra JET 7 Reperfusion Catheter is a type of catheter designed for use in neurovascular surgery, specifically in the revascularization of patients who have suffered an acute ischemic stroke—the most common type of stroke.
Acute ischemic strokes occur when a blood clot blocks an artery in the brain, cutting off blood flow to a part of the brain which quickly leads to life-threatening complications. Treatment of these strokes usually involved revascularization—the process by which the clot is removed to restore blood flow to the brain.
Revascularization can be done through the injection of an IV drug to destroy the clot or through the physical removal of the clot.
Penumbra’s reperfusion catheter is used by many surgeons in thrombectomy procedures when removing blood clots from the veins and arteries of their patients. During an imaging-guided procedure, a surgeon can insert the Penumbra catheter into the artery at the groin or wrist. The catheter can then be guided up the body to the artery which is blocked in the brain. Once the clot is secured, the catheter system reportedly uses suction to remove the clot and restore blood flow.
However, MAUDE database reports have reflected that the use of the Penumbra JET 7 Reperfusion Catheter during surgery has resulted in over a dozen deaths and over 50 injuries, challenging its reputation as a “modern medical legend.”
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