The US Food and Drug Administration issued another warning Friday about failures in artery-clearing tools made by Boston Scientific Corp. that resulted in one patient dying.
A patient died in September, four days after a wire piece broke off one of the components and perforated a vessel, according to an FDA report. Two other patients were also injured when the parts broke during operations.
Boston Scientific, based in Marlborough, had issued an “urgent medical device recall” on Oct. 9 for guide wires used in its “Rotablator” system, and the FDA earlier in November also published a recall notice.
The alert Friday said, “The use of affected product may cause serious adverse health consequences, including death.”
Boston Scientific spokesman Tom Keppeler said the company had voluntarily recalled the devices “due to the possibility of wire fracture.” He said the devices were in “limited distribution, and we have contacted all of the affected hospitals accordingly.”
In the other cases where the devices broke, also in September, doctors had to take urgent measures, including emergency surgery, to try to retrieve the wire pieces. In one instance, physicians were unable to retrieve the remnants, according to an FDA report.
The FDA said the company’s RotaWire Elite Guidewire and wireClip Torquer Guidewire are part of a system used to open narrowed arteries and improve blood flow to the heart, by cutting plaque from the artery wall.
There were 600 of the devices on the US market, the FDA said, and nearly 400 in other countries, in Europe, Japan, and South Africa, according to published reports. Keppeler said Boston Scientific alerted 30 US hospitals that had the devices.
He said the company’s standard Rotablator system, without the new components, is not being recalled.
The company has had other product problems in the past, including a major recall in 2010 of its implantable cardiac defibrillators. In 2004, Boston Scientific had recalls of its heart stents.
The firm had $1.9 billion in sales in the third quarter. Shares were little changed Friday, at $18.33; the news was released after the market’s close.