Adverse events associated with PentaRay Mapping Catheter – MAUDE database analysis

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