What Is The Penumbra JET 7 Xtra Flex Catheter?
While reperfusion catheters had existed for many years, Penumbra broke ground in the year 2007 when they introduced the first aspiration reperfusion catheter.
Penumbra’s aspiration catheters were revolutionary because they used suction to remove blood clots, something no other medical device manufacturer had done before. Aside from innovative, Penumbra’s catheter was also quite effective. So much so, in fact, that for 11 years after their introduction in 2007, Penumbra reperfusion catheters are reported to have been used in as many as 80% of thrombectomies performed in the US.
The year 2018 came around and the Penumbra JET 7 reperfusion catheter, the latest generation of Penumbra’s best-seller, was released.
The JET 7 reperfusion catheter possessed small changes but these were considered so minimal that the FDA awarded what is known as a 510(k) clearance. Essentially, the Food and Drug Administration determined that the new JET 7 reperfusion catheter was “substantially equivalent” to the Penumbra catheter already on the market and therefore Penumbra could begin to market the new device.
Soon after the JET 7 began making its way into operating rooms throughout the country, Penumbra released the JET 7 Xtra Flex Catheter and the JET 7MAX configuration, two more variations of Penumbra’s latest aspiration reperfusion catheters.
Note: The JET 7 Max configuration refers to a JET 7 Xtra Flex catheter coupled with Penumbra’s MAX Delivery Device.
What Can Go Wrong With The Penumbra Jet 7 Xtra Flex Catheter?
Since the introduction of the Jet 7 Xtra Flex and the JET 7MAX configuration, more and more instances of failure of the catheter have been reported on the FDA’s MAUDE database. This database “houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as health care professionals, patients, and consumers.“
The MAUDE device failure modes reported the following:
- Distal tip damage
- Ballooning expansion rupture breakage; while the JET 7 catheter is intended to be flexible and puncture-proof, there were instances where the tip region of the catheter would become inflated and then burst while the surgical procedure was underway
- Breakage or complete separation; leads to exposure of internal support of coils near the distal tip of the catheter
Some reports indicated distal tip damage may have been occurring as a result of surgeons employing the catheter to inject imaging agents, such as those that are necessary for postoperative angiography. As a direct response to this practice, Penumbra released contraindications related to pressurization or contrast injection via their large bore aspiration catheters such as the JET 7.
Aside from details regarding the nature of the catheter failures, the MAUDE MDRs describe serious vessel damage and other patient injuries. Unfortunately, the delicate nature of thrombectomies meant that any kind of mishap could result not only in patient injury but also death, and it wasn’t long before it did.
Patient Deaths Surface
As many as 14 deaths are believed to have resulted from Penumbra JET 7 Xtra Flex Catheter malfunctions. In many of these, the same device failures mentioned above were believed to be the culprits: damage to the internal support coils near the distal tip region resulted in breakage or complete separation of the support coils.
FDA Recall: Penumbra Jet 7 Xtra Flex Catheter in 2020
After having received over 200 medical device reports (MDRs) of incidents involving JET 7 catheters with Xtra Flex Technology, the US Food and Drug Administration (FDA) worked with the manufacturer and soon after issued recall notification.
Penumbra’s urgent voluntary recall to healthcare providers indicated that the use of any Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) was to cease immediately due to the “risk of unexpected death or serious injury while used for removing clots in stroke patients.” (FDA Urgent Letter to Health Care Providers, Dec 15th 2020)
The FDA has specified the recalled catheters to be:
- JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
- JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.”
Jet 7 Xtra Flex Recall Lawsuits
While the recall is now in effect, it is known that the Penumbra JET 7 reperfusion family of catheters has generated hundreds of millions in revenues for the manufacturer.
This means that countless unknowing victims could have been hurt by malfunctioning JET 7 catheters previous to the recent recall.
Stroke patients requiring thrombectomies are likely already in a delicate health state. Vessel damage as a result of a ballooning expansion rupture breakage of the catheter, even to a small degree, has the potential to cause death. Considering this, it’s not out of the question to wonder how many others have suffered as a result of this device failure and never learned the truth, simply because an FDA recall had not been issued?
Fortunately, the law permits victims of malfunctioning medical devices to seek compensation for damages. The most common method for achieving such compensation is by filing a defective catheter lawsuit against the manufacturer or others who may be responsible.
Compensation For Catheter Injuries
If the malfunction of a Penumbra JET Xtra Flex reperfusion device caused you, a loved one, or a friend patient injury, you may be able to seek justice via the civil justice system.
A defective catheter lawsuit, if successful, can provide victims with compensation that covers past medical expenses, future expected medical costs, pain & suffering, lost wages and more.
Given that medical device litigation tends to involve dozens if not hundreds of plaintiffs, there exists the possibility for a JET 7 Xtra Flex catheter class-action to be formed. The investigation into malfunctions of Penumbra’s device is still in the early stages, which means that no concrete group claims have been filed. Yet, if enough victims step forward with their claims, it may be a viable option to consider.
For this reason, our team highly suggests to any individuals affected by Penumbra malfunctions to reach out to our team of defective catheter lawyers.
Defective Catheter Attorneys
How much compensation you are awarded will be influenced by the legal team you chose to represent you. Make sure your rights are being defended by attorneys experienced in defective product law.
The Product Lawyers have years of experience trying defective product and medical device cases. They know what is necessary to build a strong case for compensation, and they want to help you fight for justice.
Call our 24/7 helpline for a free consultation, or fill out the form on this page to be contacted at a later time.