Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters
Abbott has issued a warning on the proper handling of its TactiFlex Ablation Catheter, Sensor Enabled, when unpackaging it because of reports that the tip can separate from the catheter. The company also said there have been three reports of the tips separating inside patients.
The U.S. Food and Drug Administration (FDA) said it is monitoring the issue after Abbott issued a letter Sept. 10 to affected customers recommending updated instructions when removing the TactiFlex from the packaging due to several reports of tip detachment.
Abbott said improper removal from the packaging can result in tip damage. While most damaged tips were detected prior to catheter insertion into patients, there have been three recent reports where tips have detached and remained in the patient. In all three cases, there were no further reported adverse outcomes to the patients. Abbott said is made changes to the packaging tray design to reduce the likelihood of tip damage during catheter removal.
As of Sept. 11, Abbott did not reported any serious injuries or deaths associated with this issue.
The company said if a tip detaches prior to insertion into the patient, the physician should replace the catheter. In the event the tip detaches during the procedure, there is the potential for embolism or migration of the detached material. This can potentially lead to respiratory compromise, hemodynamic instability, stroke, ischemia, cardiac perforation, and/or vascular injury.
The effected device product names, models and unique device identifier (UDI) numbers include:
TactiFlex SE Uni-Directional Curve D, A-TFSE-D, 05415067034656
TactiFlex SE Uni-Directional Curve F, A-TFSE-F, 05415067034670
TactiFlex SE Bi-Directional Curve F-J, A-TFSE-FJ, 05415067034618
TactiFlex SE Bi-Directional Curve D-F, A-TFSE-DF, 05415067034571
TactiFlex SE Bi-Directional Curve D-D, A-TFSE-DD, 05415067034557
The letter Abbott sent Sept. 10 recommended EP labs continue to following the product instructions for use by inspecting the packaging and catheter for damage and/or kinking prior to use. Abbott also suggested review of the guidance in Appendix A for information on proper removal technique of the TactiFlex Ablation Catheter, Sensor Enabled, from the packaging tray, ensuring to inspect the electrodes and catheter tip carefully for integrity and overall condition prior to use.
The electrophysiology ablation catheter is indicated for use in cardiac electrophysiological mapping and treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]