Penumbra: Doctors Publish Case Studies on Jet 7 Malfunctions to Highlight Risk to Peers, With More Studies Coming

Published on Oct 16, 2020

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Yesterday, three doctors in Singapore published an article in the American Journal of Neuroradiology detailing two device malfunctions involving Penumbra’s (PEN) Jet 7 catheter titled “Can a Stent Retriever Damage the JET 7 Reperfusion Catheter?” The Capitol Forum has previously reported on problems relating to the Jet 7, which can unintentionally expand in the arteries of stroke patients during routine use.

According to the abstract of the article, “this mechanical failure could potentially lead to serious complications; hence, it should be shared with fellow neurointerventionalists.” The extent of doctor awareness of the issues relating to the Jet 7 has been a point of contention among neurointerventional doctors.

In July, Penumbra sent a letter to neurointerventional doctors advising them to not inject contrast agent through the Jet 7 among other warnings.

Several neurointerventional doctors have previously told The Capitol Forum that Penumbra’s efforts to inform doctors of the risks of certain uses of the Jet 7 were inadequate given the scale of the unintentional expansion problem, with many stating that the device should be recalled.

As of today, 15 deaths stemming from the use of the Jet 7 catheter have been reported to the FDA’s device malfunction database since January.

Other doctors are also taking to medical journals to highlight those risks to their peers. Next month, several neurointerventional doctors plan to publish case studies of malfunctions, injuries, and deaths stemming from the use of Penumbra’s Jet 7 catheter in a prominent neurosurgery journal, according to a source familiar with the matter.

Those case studies will include photos and video of Jet 7 device malfunctions during surgeries, according to the source, in order to bring more awareness to the gravity of the issue.