Boston Sci Has a Guidewire Problem

FDA posted 64 adverse events related to the company's Jagwire endoscopic guidewire last month, and 500 total since 2013. FDA also recently classified another Boston Sci guidewire recall as Class I. In addition, the company just announced a recall of certain Acuity Pro coronary sinus outer guide catheters.

Nancy Crotti

FDA has classified two Boston Scientific guidewire recalls as Class I within a month's time. In addition, FDA has cataloged 500 adverse events related to Boston Scientific Jagwire endoscopic guidewire since 2013. Many of those problems relate to a detached component during use. As one of the event reports explains: "According to the complainant, during withdrawal, the hydrophilic tip became detached, exposing the tip of the metal corewire. The hydrophilic tip got detached inside the patient and was attempted to be retrieved using a retrieval basket, but failed."

The most recent guidewire to get Class I status, the Chariot Guiding Sheath, won 510(k) clearance in June as a Class II device to "deliver interventional and diagnostic devices into the peripheral vasculature," according to an agency letter to the company. The first reported adverse event involving the device occurred July 15, according to FDA records.

In November, Boston Scientific also announced a recall of certain lots of its 9Fr Acuity Pro coronary sinus outer guide catheters, citing "potential for separation of the proximal handle from the shaft."

The company states in a warning to clinicians that "if the hub and shaft are aligned off-center in the bonding equipment during manufacturing, the result may be a reduced bond, which may separate during cutting. The affected product listed below was manufactured during  the time period when the equipment was likely to be misaligned."

Also last month, the company recalled 955 RotaWire Elite guidewires from the company. 

Boston Scientific is recalling slightly fewer than 8000 of the Chariot devices sold internationally, although most were sold in the United States, according to company spokesperson Thomas Keppeler.

No patients suffered permanent injuries or died from problems associated with the Chariot Guiding Sheath devices, although one was kept in the hospital overnight, according to adverse event reports submitted to FDA between July 15 and Nov. 30, 2015.

Fourteen of the problems reported to the company involved shaft separation during preparation for a procedure or during use, including four reports of separation of the distal shaft, the Marlborough, MA, company said. "These events occurred during device preparation or use," spokesperson Thomas Keppeler explains. FDA has listed 22 reports, of which two covered the same incidents.

Many of the reports to FDA cited delamination of the Chariot's inner sheath and difficulty in removing the device from patients. In one instance, a sheath broke off during removal and remained inside the patient.

"The surgeon then made a small incision and was able to fish out the remaining portion of the chariot guiding sheath," and the patient was "fine," according to the FDA event report.

In another instance, a physician felt "something funny" while advancing a stent through a Chariot sheath inside a patient. The stent came off the balloon inside the sheath, according to an FDA report. When the physician tried to remove the sheath, "the hub separated and the braiding began unwinding." No patient complications were reported and the patient's status was listed as "normal."

One patient died September 30, four days after a RotaWire Elite broke inside a patient's artery. The attached burr of the device perforated the vessel, according to the FDA adverse event report.

"We have an unwavering commitment to delivering products that meet the highest quality standards," Keppeler wrote in an email statement regarding the Chariot device. "We take matters such as this very seriously, and make decisions that place our customers and patients first. We are committed to resolving this issue and restoring available inventory as soon as possible to meet customer needs."

The RotaWire Elite and Chariot recalls are unrelated, Keppeler added. The company sold the RotaWire Elite to 30 hospitals, also as part of a "limited release."

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