Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its TactiCath Quartz Contact Force Ablation Catheter [Model PN-004 065 and PN-004 075; GTIN: 07640157990033 and 07640157990040].
The manufacturer is notifying users of a high rate of reported complaints for loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter.
According to the manufacturer, loss of contact force information during use of the affected products has been reported at a rate of 4.3% (out of 84,104 catheters distributed) over a 26-month period. Among them, 33% of the reported complaints occurred prior to catheter insertion (complaint rate of 1.4%) and 67% of the reported complaints occurred during the procedure (complaint rate of 2.9%).
Based on the manufacturer's device risk analysis, loss of contact force information could result in:
- Ineffective ablation potentially resulting in an increased risk of atrial fibrillation recurrence or need for repeat procedure
- Potential risks associated with the insertion of a replacement catheter or catheter exchanges such as air embolism, extended exposure to anesthesia and fluoroscopy, infection, and bleeding
- Potential for cardiac perforation and all associated patient harms such as tamponade
- Clinically significant or minor delays in procedure
The manufacturer recommends the following steps to help prevent TactiCath Quartz contact force failures:
- Always cover unused optical cable ports on the TactiSys 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
- Clean the connectors and carefully secure all connections between the catheter, console and mapping system at the beginning of each procedure (refer to user manual for details)
- Exercise the catheter deflection mechanism and test the force sensor prior to insertion
- When using TactiCath Quartz with a steerable sheath, make sure the sheath tip is straight when catheter tip is inserted. Try to keep the steering plane of TactiCath Quartz and the sheath aligned to reduce stress on the catheter.
The manufacturer recommends the following troubleshooting sequence if force sensing is lost prior to or during the procedure:
- Re-check and clean the connections between the TactiCath Quartz Catheter, TactiSys Equipment and Ensite mapping system (refer to user manuals for details)
- Replace the first failed TactiCath Quartz catheter with a second TactiCath Quartz catheter
- If two TactiCath Quartz catheters fail, consider using different TactiSys Equipment for the procedure if available.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 May 2020