Device Malfunctions Related to the "Spyglass" Cholangioscope During ERCP: A MAUDE Database Analysis

Introduction: Spyglass cholangioscopy is a frequently used device during endoscopic retrograde cholangiopancreatography (ERCP). A spyglass cholangioscope comprises several parts like a spyglass catheter, snare, biopsy forceps, lithotripters, etc. Despite its well-established safety, the real-world adverse events of this device remain unknown. The primary objective of our study was to assess the device and device-associated malfunctions reported with the Spyglass cholangioscope use during ERCP utilizing the post-marketing surveillance data from the food drug administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The FDA MAUDE database compiles information on reported adverse effects of medical devices. A retrospective analysis of the MAUDE database of all spyglass-related reports from June 2021 to February 2023 was conducted. The data included details of complications, procedural information, outcomes, and the need for rescheduling. Results: We found 125 reported adverse events with a total of 190 complications associated with Spyglass cholangioscope use during ERCP (Table 1). The most common complications were optical/screen-related issues (n=72, 38%), including fragmented or blurred images and image loss due to connection problems (n=49, 26%). There were 64 (33.7%) reports related to mechanical issues, including breakage of the pull-wire (n) and a failure of the snare loop to open. Other device-related problems included the failure of the spybasket to open (n=5). Additionally, 1 event involved the stripping away of the jacket on the guidewire from the inner shaft of the spyglass. Most complications occurred intraoperatively. Four procedures led to infectious events, including 1 patient who developed cholangitis, resulting in an extended hospital stay requiring antibiotics and repeat ERCP. Out of the procedures, 110 were aborted (88%), and 22 (17.6%) required rescheduling. Conclusion: Our study offers valuable insights into uncommon real-world adverse events reported with Spyglass cholangioscopy. Information regarding these complications can aid physician preparedness in managing them and also guide informed decision-making for patients. Future research should assess the actual incidence of these AE and explore methods to mitigate them. Table 1. - Outcomes and prevalence complications associated with SPYGLASS cholangioscope during ERCP Outcomes Aborted = 110 Rescheduled = 22 Adverse events Optical complication Image unclear 72, (38%) Image lost 49, (26%) Mechanical Device break 4 (2%) Device malfunction 60 (32%) Others Infection 4 (2%) Contamination 1 (< 1%)