In 2019, Bard Peripheral Vascular Inc (BV; now Becton, Dickinson and Company; Sparks, Maryland) received FDA approval to begin marketing the The WavelinQ™ EndoAVF System through a process known as 510(k) authorization. Such authorization relies on BV proving that the new WavelinQ™ EndoAVF System was of "substantial equivalence" to the WavelinQ™ 4F EndoAVF System. We set forth to analyze patient problems and device issues reported for the new device and determine if they were significantly different from the predicate device its 510(k) approval was based on. FDA database Manufacturer and User Facility Device Experience (MAUDE) was queried for all adverse report events for the WavelinQ™ EndoAVF System and WavelinQ™ 4F EndoAVF System. Data was collected on patient issues and device issues. Fisher's Exact test was utilized. There was a total of 125 reports for the WavelinQ™ 4F EndoAVF System and 78 for the WavelinQ™ EndoAVF System. There was a significant increase in patient problem "hypertension" (0% vs. 5.1%; p=0.02) for the WavelinQ™ EndoAVF System but a statistically significant decrease in device issue "failure to align" for the WavelinQ™ EndoAVF System (24.8% vs. 10.3%; p=<0.01). There were changes in device and patient outcomes between the WavelinQ™ EndoAVF System and WavelinQ™ 4F EndoAVF System. While we noted a decrease in device problem "failure to align", there was an overall increase in patients' "hypertension" rates. This highlights the importance of the FDA MAUDE reporting in ensuring that device safety is maintained when devices are approved for marketing through the 510(k) process.