UPDATE: FDA deems Boston Scientific’s atherectomy component recall Class I

The FDA last week slapped Class I status on Boston Scientific‘s (NYSE:BSX) recall of nearly 1,000 components used with its Rotablator atherectomy device.

Boston Scientific warned doctors of the potential problem in October, after receiving 3 reports that the catheter’s guidewire fractured during procedures to remove plaque from the coronary arteries. In 1 case, the patient died 4 days after the wire fractured and the device’s rotating burr, moving at 195,000 to 200,000 rpm, pierced the artery wall, according to the FDA’s adverse events database.

The federal safety watchdog’s Class I recall status denotes the risk of serious injury or death.

In the Oct. 8 letter, Marlborough, Mass.-based Boston Scientific said it was recalling 955 of the RotaWire Elite and WireClip torquer components.

“During the limited market release, Boston Scientific has received 3 complaints for wire fracture. One fracture occurred during device prep, and the other 2 fractures occurred during the procedure resulting in burr migration into the pericardium. One of these involved placement of a covered stent to address vessel perforation. That patient subsequently expired. The other required surgery for removal of the fragment,” according to the letter.

The FDA, in labeling the recall as Class I, said the cause was a component change control; in June, Boston Scientific won approval from the federal safety watchdog to change its core wire vendor and rebrand the RotaWire as the RotaWire Elite.

According to an Oct. 1 report in the FDA’s Manufacturer & User Facility Device Experience database, the RotaWire Elite fractured during a Sept. 30 procedure to ablate plaque in a heavily calcified lesion in the ostial/proximal right coronary artery, perforating the vessel.

“The burr and part of the wire was removed; however, 20-30cm of the distal wire was left inside the patient. A non-[Boston Scientific] covered stent was deployed to seal the vessel perforation. Four days later, the patient died,” according to the MAUDE report.

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