356 Pigtail Catheter Insertion Error: Root Cause Analysis and Recommendations for Patient Safety

Abstract

Small caliber chest tubes are used to treat pneumothorax and pleural fluid collections. Emergency physicians must be familiar with common and dangerous procedure complications associated with these devices and have a systematic and rapid approach to identify and solve malfunctions. Structured root cause analysis can facilitate identification of problems. Using a structured review process, we analyzed two cases of retained pigtail catheter obturators, resulting in catheter malfunction and unresolved pneumothorax. We used a stepwise root cause analysis to identify sequential opportunities to avert the errors, applied an Agency for Healthcare Research and Quality rubric to categorize error sources, and applied a usability heuristics model to identify engineering and device design improvements. The case reviews were exempted by the IRB. We identified multiple contributing factors, including unrecognized and novel radiographic clues (Figure 1), human errors, communication breakdown, device design flaws (Figure 2), and opportunities for improved systematic procedural approach. We reported the errors and recommendations to the manufacturer and United States Food and Drug Administration (FDA). A structured review of complications of pigtail catheter insertion revealed opportunities for improved patient safety. We highlight a preventable error in insertion of a percutaneous catheter and describe radiographic features to enhance error detection. Improved design, systematic processes for device insertion and troubleshooting, and enhanced provider education could reduce the risk of medical device errors. An end-of-procedure time-out including instrument counts and systematic assessment of device function are generalizable patient safety measures for bedside procedures. We discuss regulatory considerations relevant to emergency physicians, including FDA reporting mechanisms.Figure 2Luer-lock connectors on the catheter obturator and tissue dilator serve no purpose and create a risk of error. The external drainage tube can be inadvertently connected to these devices, rather than to the 14 French catheter.View Large Image Figure ViewerDownload Hi-res image Download (PPT)