Modes of failure with fractional flow reserve guidewires:Insights from the manufacturer and user facility device experience database

BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.

Complications associated with energy-based devices during thyroidectomy from 2010–2020

Objective:Harmonic Focus(Ethicon,Johnson and Johnson,Cincinnati,OH,USA),LigaSure Small Jaw(Medtronic,Covidien Products,Minneapolis,MN,USA),and Thunderbeat Open Fine Jaw(Olympus,Japan)are electrosurgical instruments used widely in head and neck surgery.The study aims to compare device malfunctions,adverse events to patients,operative injuries,and interventions related to Harmonic,LigaSure,and Thunderbeat use during thyroidectomy.Methods:The US Food and Drug Administration's Manufacture and User Facility Device Experience(MAUDE)database was queried for adverse events associated with Harmonic,LigaSure,and Thunderbeat from January 2005 to August 2020.Data were extracted from reports pertaining to thyroidectomy.Results:Of the 620 adverse events extracted,394(63.5%)involved Harmonic,134(21.6%)LigaSure,and 92(14.8%)Thunderbeat.The reported device malfunctions most frequently associated with Harmonic was damage to the blade(110(27.9%)),LigaSure was inappropriate function(47(43.1%)),Thunderbeat was damage to the tissue or Teflon pad(27(30.7%)),respectively.Burn injury and incomplete hemostasis were the most commonly reported adverse events.The operative injury reported most frequently when using Harmonic and LigaSure was burn injury.No operator injuries were reported with Thunderbeat use.Conclusion:The most frequently reported device malfunctions were damage to the blade,inappropriate function,and damage to the tissue or Teflon pad.The most frequently reported adverse events to patients was a burn injury and incomplete hemostasis.Interventions aimed at improving physician education may help reduce adverse events attributed to improper use.