Summary Safety Review - TactiCath Quartz - Assessing the potential risk of compression of the heart (cardiac tamponade)

November 23, 2017

Product

TactiCath Quartz by Abbott (formerly St. Jude Medical)

Potential Safety Issue

Risk of compression of the heart due to fluid buildup around it (cardiac tamponade)

Key Messages

  • TactiCath Quartz is a medical device authorized for sale in Canada. It is used in heart procedures to treat patients with unusual heartbeats (i.e., arrhythmias).
  • Health Canada reviewed the potential risk of compression of the heart due to fluid buildup around it (i.e., cardiac tamponade) after receiving Canadian reports associated with the use of TactiCath Quartz.
  • Health Canada’s review of the available information concluded that there is a potential link between the use of TactiCath Quartz and the development of cardiac tamponade. However, the risk is known and is not specific to the device itself, as it is also associated with the heart procedure. The current Instructions for Use for TactiCath Quartz does mention this risk.
  • Health Canada encourages healthcare professionals to follow the Instructions for Use given by the manufacturer when using this device, and to report any side effects associated with its use.
  • Health Canada will continue to monitor this safety issue and reassess if new information becomes available.

Overview

Health Canada reviewed the potential risk of compression of the heart due to fluid buildup around it (i.e., cardiac tamponade) after receiving Canadian reports associated with the use of TactiCath Quartz. This risk is known and labelled in the current Instructions for Use for TactiCath Quartz.

Use in Canada

  • TactiCath Quartz is a medical device authorized for sale in Canada to treat patients with unusual heartbeats (i.e., arrhythmias) when drugs have not helped. It is used only by qualified heart specialists (i.e., cardiologists) in hospital or clinical settings. It is a flexible tube (catheter) put into the heart to deliver heat to treat the tissues in the heart that cause the unusual heartbeats.
  • TactiCath Quartz has been marketed in Canada since 2015.

Safety Review Findings

  • At the time of the review, Health Canada had received a total of 16 unique Canadian reports of fluid buildup around the heart (i.e., pericardial effusion) associated with the use of TactiCath Quartz either during or shortly after the procedure. Of the 16 cases, 3 led to cardiac tamponade due to excess fluid around the heart. In 12 of the 16 patients, the fluid needed to be drained, while the remaining 4 patients required no treatment.
  • A review of the published literature indicated that fluid buildup around the heart leading to cardiac tamponade can happen during or shortly after these kinds of heart procedures. The risk is known, but it is not specific to any particular catheter device or manufacturer. It is believed that less than 1 in 100 patients have experienced these issues when TactiCath Quartz was used. This amount is comparable to patients having these heart procedures with other brands of devices.
  • Factors that can add to the risk of cardiac tamponade may include, but are not limited to:
    • moving the catheter with too much force; and
    • treating or applying too much heat to an affected area for too long.

Conclusions and Actions

  • Health Canada’s review of the available information concluded that there is a potential link between the use of TactiCath Quartz and the development of cardiac tamponade. The risk is known and labelled in the Instructions for Use for TactiCath Quartz.
  • Health Canada encourages healthcare professionals to follow the Instructions for Use given by the manufacturer when using this device to treat patients and to report any side effects associated with its use.
  • Health Canada will continue to monitor safety information involving TactiCath Quartz, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of these products both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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