Post written by Saurabh Chandan, MD, from the Creighton University School of Medicine, Omaha, Nebraska, USA, and the Center for Interventional Endoscopy, Advent Health, Orlando, Florida, USA.

The primary aim of our study was to assess and report all adverse events (AEs), including those device- and patient-related, associated with the single-operator cholangioscopy (SOC) system (SpyGlass; Boston Scientific, Marlborough, Mass, USA), as reported in the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database between January 2016 and August 2023.

Although SOC is considered a safe procedure, it may add risks to those associated with standard ERCP. Prior studies on cholangioscopy have reported a pooled AE rate of 7%, which included pancreatitis (2%), cholangitis (4%), and perforation (1%). However, data on device-related failures and patient-related events pertaining to SOC using the SpyGlass system are limited.

In our database search, 2311 device problems (SpyGlass DS, 1301; SpyGlass DS II, 1010) were reported. An optical problem was the most commonly reported issue (SpyGlass DS, 83; SpyGlass DS II, 457) while other reported issues were poor-quality images (157 reports) and material protrusion or extrusion defects (1061 reports) for both devices.

In terms of patient-related AEs, the most common were bleeding in 15 cases; perforation in 14; infection, fever, or sepsis in 6; and pancreatitis in 6. Pancreatitis was reported only with the SpyGlass DS II. Our findings add to the growing body of literature regarding the safety of single-operator cholangioscopes and their accessories.

Our results should be considered with an important limitation of the MAUDE database: All indexed events are electively reported. Therefore, under-reporting, potential inaccuracies, and lack of verification may underestimate device failure and AE rates.

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