Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis.
Gastrointest Endosc
; 99(6): 1035-1038, 2024 06.
Article
en En
| MEDLINE
| ID: mdl-38316225
ABSTRACT
BACKGROUND AND AIMS:
The SpyGlass (Boston Scientific, Marlborough, Mass, USA) single-operator cholangioscopy (SOC) system is generally considered to be safe but adds additional risks to those associated with standard ERCP.METHODS:
We evaluated adverse events (AEs) associated with the SpyGlass system reported in the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database between January 2016 and August 2023.RESULTS:
From the database, 2311 device problems (SpyGlass DS, 1301; SpyGlass DS II, 1010) were reported. An optical problem was the most reported issue (SpyGlass DS, 83; SpyGlass DS II, 457). Patient-related events were found in 62 of 1743 reports (3.5%) 33 with the SpyGlass DS and 29 with the SpyGlass DS II. The most common AEs were bleeding/hemorrhage followed by perforation; infection, fever, or sepsis; and pancreatitis.CONCLUSIONS:
Our findings add to the existing literature and provide a fuller picture of potential problems associated with the SpyGlass SOC.
Texto completo:
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Banco de datos:
MEDLINE
Asunto principal:
Bases de Datos Factuales
/
Endoscopía del Sistema Digestivo
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Año:
2024
Tipo del documento:
Article