The airline has been named as a defendant in several lawsuits stemming from the Jet 7 disaster. The company faces claims including negligence and wrongful death, but it is trying to limit liability through its recall program.
Is the Catheter from Penumbra, Inc. safe?
As of Oct. 31, 2020, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database has received 18 fatality reports using the Penumbra.
Patients have died as a result of artery ruptures in numerous instances. The rupture happened in the internal carotid artery, which feeds blood to the brain and eyes in some of these instances. Damage to the distal tip was linked to several of the observed ruptures.
A patient died when the tip of the Penumbra catheter came off within the body during a revascularization operation, according to an early September 2019 report. When the catheter was withdrawn, the coils at the device’s tip were “unwound” and “frayed,” according to the doctor.
A more recent case included the death of a COVID-19 patient who contracted the virus and died after surgery with the faulty Penumbra catheter. The tip of the Penumbra catheter allegedly broke during this patient’s surgery. When the faulty catheter was discovered, the operation was stopped, and the COVID-19 patient died of “stroke and intracranial pressure problems.”
The tip of the Penumbra catheter may break during surgery, according to several MAUDE accounts. Significant problems, including as vascular ruptures, bleeding, and death, may result.
Over 40 complaints of harm during operations using the faulty Penumbra catheter are also included in MAUDE.
A patient was injured in July 2020 when the surgeon discovered a carotid-cavernous sinus fistula (CCF), which is usually caused by trauma. “The ccf was claimed to be linked to the jet7,” according to the study.
In June 2020, a similar incident was recorded in which the patient suffered a CCF. “The carotid cavernous fistula was found to be linked to the jet7,” according to the study.
One surgeon tried to remove the Penumbra catheter and noted that “upon removal of the jet7, the patient’s head twisted as if responding to pain,” according to a startling report. The report concludes by noting that the patient’s medical condition is unclear.
The MAUDE database contains many of these and similar reports.
READ MORE: What You Need to Know About Penumbra Catheter Complications
Is the Penumbra JET 7 Xtra Flex Catheter being recalled?
Penumbra, Inc. announced an urgent voluntary recall of its Penumbra JET 7 Extra Flex catheter on December 15th.
This occurred little over a month after Quintessential Capital Management managing partner Gabriel Grego wrote a brief thesis labeling the Penumbra Jet 7 “unsafe and unmarketable.”
According to Forbes, another well-known hedge fund manager, Marc Cohodes, has pledged to assist Grego in his efforts to “get this very poor and hazardous product off the market.”
This would not be Penumbra’s first public relations disaster with a faulty medical equipment.
Penumbra’s revascularization device was recalled in 2007. Penumbra issued a recall for its Penumbra 3D Revascularization device owing to concerns that the device’s delivery wire may break during usage, potentially leaving broken wire fragments in a patient’s brain.
Penumbra’s recent recall of the JET 7 Xtra Flex catheter occurred weeks after the press revealed that the Alameda-based business had been refusing to accept responsibility for their faulty product. In reaction to the breaking news, the company allegedly issued a “Notification to Healthcare Providers.”
Rather of taking responsibility for the flaw, Penumbra, Inc. cautioned doctors about the danger of tip rupture when contrast is administered via the catheter, and advised surgeons to use a guide catheter instead.
The Penumbra healthcare provider notification explains that the “JET7 Xtra Flex may become susceptible to expansion or rupture during contrast injection due to distal tip weakening from manipulation against resistance or use with other manufacturers’ revascularization devices,” and that “[d]istal tip expansion or rupture may cause vessel damage and subsequent patient injury or death.”
READ MORE: Injuries Associated With The Jet 7 Xtra Flex Stroke Catheter