SPYGLASS RETRIEVAL BASKET

Additional Manufacturer Narrative

BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF IMPACT CODE F2301 CAPTURES THE USE OF SPY AN EHL TO BREAK THE STONE AND REMOVE THE STUCK BASKET. IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO RELEASE STONE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE DEVICE BECAME IMPACTED ON THE STONE, THE HANDLE HAD TO BE CUT OFF AND THE ENTIRE SYSTEM WAS REMOVED. THE PHYSICIAN USED SPY AND EHL TO BREAK THE STONE AND REMOVE THE STUCK BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.