The notice out of Germany, dated May 28, warns on complaints regarding a loss of contact force information while using the TactiCath product. This issue could cause ineffective ablation that could lead to atrial fibrillation (AF) recurrence or need for the procedure to be repeated.
Other risks include those associated with the insertion of a replacement catheter or catheter exchanges, the potential for cardiac perforation and associated harms and clinically significant or minor delays in the procedure.
Abbott said in the notice that, over a 26-month period, more than 3,600 of 84,104 (4.3%) catheters distributed had loss of contact force information reported.
In total, there were 2,985 cases in which a single catheter was exchanged due to the issue and 381 cases in which three, four or five catheters were needed. Twice, the procedure was unable to be completed and there were three cases of cardiac perforation or tamponade where contact force failure could not be ruled out as a potential cause.
Abbott recommends that users always cover unused optical cable ports on TactiSysTM equipment with the protection cap when not in use, carefully disengage the catheter from the packaging tray to avoid damage to the contact force mechanism and clean the connectors and carefully secure all connections at the beginning of each procedure.
Other suggestions include exercising the catheter deflection mechanism and testing the force sensor prior to insertion and making sure that, when using the catheter with a steerable sheath, the sheath tip is straight when the catheter tip is inserted.