The electrophysiology business Abbott (NYSE:ABT) built around its $250 million acquisition of Topera Medical this month warned physicians about the risk that the splines on some of its Firmap catheters could fracture.
Abbott EP said it received 16 reports of catheter spline fracture from October 2013 to April 18, for an incidence rate of less than 0.4%. There were no injuries related to the fractures and the catheter was safely removed in all cases, according to the May 3 letter.
The company cautioned against torquing the catheter or forcing it against excessive resistance. Manual pre-bending at the distal end can damage the catheter’s basket, Abbott EP said, warning against rotating or torquing the catheter when the basket is collapsed within the delivery sheath.
The December 2014 buyout of Topera, along with a right-to-buy deal with Advanced Cardiac Therapeutics and its TempaSure ablation catheter, marked Abbott’s entrance into the electrophysiology arena.