[Risk Analysis of Intravascular Shockwave Catheter and Discussion of Critical Control Points throughout Life Cycle].

Abstract

This study summarizes the clinical application, technical characteristics, and production process of intravascular shockwave catheters. It collects statistics on adverse events of related products from the MAUDE database, analyzes the causes of adverse events and failure modes of intravascular shockwave catheters, and identifies risk points. Based on the whole life cycle management method of medical devices, combined with product risks and the requirements of Good Manufacturing Practice for Medical Devices and related appendices, the critical control points of such products in the design and development, manufacturing, sales, and use stages are discussed.