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Updated: Jun 21, 2025
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Published on: May 26, 2015
Catheter-related and clinical complications associated with QDOT MICROTM Ablation Catheter
Jakrin Kewcharoen1, Kuldeep Shah2, Rahul Bhardwaj1
1Division of Cardiology, Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, California, USA.
Introduction:
The QDOT MICROTM Ablation Catheter is a next-generation ablation catheter that allows for high-power ablation up to 90 watts.
Methods:
We aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter.
Results:
A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter-related issues and 154 (51%) clinical complications. Among the catheter-related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade).
Conclusion:
As high-power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter-related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.
Insights
The QDOT MICRO™ Ablation Catheter, used for high-power ablation, has reported adverse events including catheter damage and clinical complications like pericardial effusion. Further data are needed to enhance safety and efficacy.
Area of Science:
- Cardiovascular Interventions
- Medical Device Safety
Background:
- The QDOT MICRO™ Ablation Catheter enables high-power ablation up to 90 watts.
- Next-generation ablation catheters are increasingly utilized in clinical practice.
Purpose of the Study:
- To assess adverse events (AEs) associated with the QDOT MICRO™ Ablation Catheter.
- To analyze catheter-related issues and clinical complications reported in the MAUDE database.
Main Methods:
- A comprehensive search of the MAUDE database was performed on May 25, 2024.
- All AEs linked to the QDOT MICRO™ catheter since its FDA approval were captured.
Main Results:
- A total of 302 AEs were reported between November 2022 and April 2024.
- Catheter-related issues (49%) included physical damage (74.3%), while clinical complications (51%) were led by pericardial effusion (43.5%).
- Eleven deaths were reported, associated with esophageal complications, cardiac arrest, and pericardial effusion with cardiac tamponade.
Conclusions:
- Operators using high-power ablation catheters must be aware of potential complications.
- Additional research is necessary to fully understand and mitigate the risks associated with these devices, improving their safety and efficacy.
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