Boston Scientific Corp.’s Maple Grove office has recalled more than 900 RotaWire Elite guide wires used to clear severely clogged vessels in the legs, following reports of device failures including one in a patient who later died.
The Massachusetts-based medical device-maker got permission from the FDA in June to change its core wire suppliers and rebrand the guide wires as RotaWire Elite. The rebranded Elite wires were rolled out in a limited release to about 30 hospitals earlier this year, including providers in Minnesota. All of them have since been recalled.
The recall does not affect traditional RotaWire Guidewires, which are used with the company’s Peripheral Rotablator Atherectomy System to poke through hardened leg-vessel lesions and guide the system’s tiny diamond-tipped burr to the blockage.
The rebranded RotaWire Elite is used for the same purpose, with the same atherectomy system. The wire is .009 inches wide.
On Oct. 9, the company notified hospitals that it was stopping sales of RotaWire Elites and asking for all 955 of them in the field to be returned. The Food and Drug Administration later characterized the letter as a Class 1 recall, the most serious type, and on Nov. 13 notified the public about it.
A copy of the voluntary recall letter on file with the German Federal Institute for Drugs and Medical Devices says the company learned of three incidents in which RotaWire Elite wires fractured, including one during prep and two during actual atherectomies. One of those patients died.
According to a report on file in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, an unidentified doctor on Sept. 30 was using a RotaWire Elite when the wire fractured unexpectedly.
The fracture caused the diamond-tipped burr, spinning at 190,000 revolutions per minute, to perforate the wall of the patient’s right coronary artery, the MAUDE report says. The doctor used a stent from a different company to try to seal the vessel.
“Four days later, the patient died,” the MAUDE report says without further elaboration.
The FDA’s public recall notice says the agency-determined cause of the recall was a change in manufacturing practices.
A spokesman for Boston Scientific declined to comment.
The RotaWire Elite is the third Boston Scientific device that was the subject of a Class 1 recall this year. In January, the FDA announced a company recall of three sizes of its still-experimental Lotus transcatheter aortic valve implant in Europe because a design issue had allowed the valve to become unlocked from the delivery catheter unexpectedly.
In March, the FDA announced a company recall of 14 experimental IntellaTip ablation catheter units in Europe after reports of “formation of char” on the device’s electrodes.