To acknowledge an error risks a stock selloff, bad publicity and possible litigation, as well as reduced executive pay and maybe even a few resignations. The alternative β covering up the blunder β could turn what is a professional embarrassment into a potential regulatory headache or even a criminal investigation.
The leaders of Penumbra, an extraordinarily successful Alameda, California β based manufacturer of neurovascular devices, have recently found themselves on the horns of this very dilemma. But voluntary reports submitted to a Food and Drug Administration database, including entries from surgeons who have used the new catheter, paint a picture of a device whose safety problems Penumbra may be forced to address in more substantial terms than the July 27 release.
Introduced with much fanfare at a key industry conference in July , the Jet 7 Xtra Flex is an aspiration catheter designed for use in a procedure called a suction thrombectomy. As shown in a brief Penumbra video clip, an aspiration catheter is a thin tube that can be inserted inside a person through an opening at the groin or wrist.
Guiding the catheter to an arterial brain clot, a surgeon then uses suction to remove it. In Penumbra received the first FDA approval to market an aspiration catheter designed to treat individuals who had experienced strokes. Following this, several clinical studies demonstrated the benefits of using an aspiration catheter for interventions after acute ischemic strokes, leading Penumbra to introduce several generations of its pioneering device.
From to , some 80 percent of all the suction thrombectomies performed in the United States relied on Penumbra aspiration catheters, according to brokerage analysts. A research report that aggregated U. The MAUDE database has one such report of a death after an operation last year; Penumbra rolled out the new catheter commercially in mid MAUDE is an informal, voluntary reporting system for public tracking of adverse events like injuries and deaths involving any piece of medical equipment approved for use in the U.
