Adverse events associated with PentaRay Mapping Catheter – MAUDE database analysis

Abstract

Abstract Background The 20 pole PentaRay Mapping Catheter is a high-definition mapping catheter with five soft, flexible spines providing better and faster acquisition. Despite its design, the catheter is not without glitches. Objective We queried the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database for adverse events related to the use of the PentaRay mapping catheter. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was searched for reports received between October 1, 2019, to October 31, 2021, to capture all adverse events associated with PentaRay mapping catheter using the term “PentaRay” in the “brand name” section. The adverse events were adjudicated to various categories based on the review of the event description for each medical device report (MDR). Results A total of 159 events were reported in 148 MDRs during the study period. The most common device related issues were: damaged splines 18.2% (n=29), device entrapment 17% (n=27), thrombus on device 15.1% (n=24), foreign material on splines 8.8% (n=14), sensor error 3.8% (n=6). Of the patient related events, 13.8% (n=22) were pericardial effusion, 5% (n=8) cardiac arrest, 1.2% (n=2) coronary vasospasm/STEMI, 0.6% (n=1) heart block, 0.6% (n=1) air embolism, 0.6% (n=1) tear in pulmonary veins. These events lead to procedure abortion 27.7% (n=44) and procedural delay 11.3% (n=18). Conclusion Several issues have been reported with the PentaRay mapping catheter leading to to procedure abortion, delay and patients related adverse events. Understanding and troubleshooting may help improve patient outcomes. Funding Acknowledgement Type of funding sources: None.