The FDA has recently issued an early alert highlighting a critical concern with Abbott’s TactiFlex Ablation Catheter, Sensor Enabled. This notification is of particular importance for clinical, quality, and regulatory professionals involved in electrophysiological procedures. The alert addresses risks associated with catheter tip detachment during removal from its packaging, potentially leading to severe patient outcomes in rare cases.
What Changed?
Following the identification of tip detachment incidents, Abbott has revised its handling instructions for the TactiFlex Ablation Catheter. Packaging design updates have been implemented to minimize risks during catheter removal. Customers received a letter from Abbott on September 10 outlining revised usage instructions and the need for stricter pre-use inspections.
Who is Affected?
The alert pertains to healthcare providers using the TactiFlex Ablation Catheter, Sensor Enabled, for cardiac electrophysiological mapping and the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter. This device is used in conjunction with an RF generator and three-dimensional mapping systems.
What to Do
Healthcare professionals should adopt the following measures to address this issue:
- Inspect both the packaging and catheter for damage or kinking prior to use.
- Ensure the catheter’s distal tip is fully retracted from the tip protector before lifting it out of the packaging tray to avoid damage.
- Review Abbott’s guidance in Appendix A for proper catheter removal techniques.
- Complete the acknowledgement form provided by Abbott to confirm awareness and understanding of the advisory notice.
Risks and Detected Events
The issue stems from improper catheter removal methods that may cause the tip to detach. While most problems have been identified before use, there have been three cases where catheter tips detached and remained inside patients. These instances did not result in adverse patient outcomes. However, tip detachment during a procedure poses risks of embolism, stroke, ischemia, cardiac perforation, and vascular injury.
Abbott reported that as of September 11, no serious injuries or deaths have been linked to this issue. Modified packaging is being distributed to better protect the catheter tip during handling.
Importance of UDI
The unique device identifier (UDI) allows healthcare teams, regulators, and manufacturers to track medical devices from production to patient use. Accurate UDI data supports swift responses to adverse events and device faults, ensuring both safety and accountability in device management systems. For resources on identifying UDI on labels, professionals can visit the AccessGUDID database for more guidance.
Reporting Issues
Healthcare providers and patients can report concerns or adverse reactions through MedWatch, the FDA’s safety and adverse event reporting program. Additionally, U.S.-based customers with device-related questions can contact Abbott customer support at 1-855-478-5833 for assistance.
Recap and Next Steps
Abbott’s efforts to revise packaging and improve training aim to mitigate risks associated with the TactiFlex Ablation Catheter. Healthcare teams should follow updated IFUs, inspect devices prior to use, and contact Abbott for further clarification. Regulatory professionals must stay updated through the FDA webpage as new developments emerge in this alert.
Disclaimer
This content is for informational purposes only and does not constitute legal, clinical, or regulatory advice. Professionals should refer to FDA guidance and Abbott communications for official instructions.
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-tactiflex-ablation-catheter-issue-abbott